Medical Device Alerts - MDA's - 2003 - 2012

The following Medical Device Alerts were issued between 2003-2012

2003 - 2012

Reference  Date of Issue Title 
MDA/2012/079 19 November 2012 Samaritan public access defibrillator - risk of failure to deliver therapy. (HeartSine) may repeatedly turn on and off when not in use, switch off after delivering a single shock or give a premature low battery warning.
MDA/2012/075 25 October 2012 All medical devices and medicinal products containing chlorhexidine - Risk of anaphylactic reaction due to chlorhexidine allergy. (Various manufacturers) Check labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy. 
MDA/2012/072 18 October 2012 AlboGraft polyester vascular graft - sales of AlboGraft now permitted in the UK. (Pace Medical and distributed in the UK by APC Cardiovascular) Grafts should be leak tested prior to use until end of December 2012.
MDA/2012/070 9 October 2012 External pacemaker - risk of under-sensing or output failure when used on patients with epicardial pacing wires. (Pace Medical and distributed in the UK by APC Cardiovascular) Do not use these pacemakers with epicardial pacing wires until they have undergone 3 upgrades
MDA/2012/062 11 September 2012 Silicone tracheostomy tubes - eyelets of silicone tracheostomy tubes damaged by holder. (Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss.
MDA/2012/061 10 September 2012 Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads Manufactured by St Jude Medical. This Medical Device Alert has been issued as there is a risk of inappropriate shock or therapy failure due to wear of lead insulation when using implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical.
MDA/2012/038 28 June 2012 Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) – failure to appropriately decontaminate. (Invacare) Should be appropriately decontaminated between each patient use.
MDA/2012/036 25 June 2012 Metal-on-metal (MoM) hip replacements - updated advice with patient follow ups. (All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements
MDA/2012/022 25 April 2012 Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation - diagnosis of breast cancer difficult in some cases. (Q-Med AB - a Galderma division) problem with use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult
MDA/2012/020 12 April 2012 Oral swabs with a foam head - heads may detach during use. (All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients.
MDA/2012/014 16 March 2012 Implantable cardioverter defibrillators (ICD) - risk of loss/ pacing therapy. (Medtronic) once elective replacement indicator (ERI) is reached there is a risk of loss of ICD/pacing therapy from rapid battery depletion that occurs around 2.5 years after implantation
MDA/2012/011 15 March 2012 Silicone gel filled breast implants - updated information on filler. (Poly Implant Prothese (PIP) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler.
MDA/2012/009 1 March 2012 Level 1® Normothermic IV fluid administration sets (specific models) - risk of fluid / blood loss or delay in therapy. (Smiths Medical) increase in reports of disconnections of the Luer lock connector for model numbers D-60 HL and DI-60HL at the patient end of the tubing for these fluid warming sets, which can lead to a risk of fluid/ blood loss or delay in therapy. 
MDA/2012/005 16 February 2012 Stapler Duet TRS™ universal straight and articulating single use loading units (SULU) - do not use for adult or paediatric thoracic surgery procedures. (Covidien) reports of serious injuries after use of Stapler Duet TRS™ loading units in the thoracic cavity.
MDA/2011/108 1 December 2011 Auxiliary common gas outlet (ACGO) for anaesthetic machine - no fresh gas flow to patient with wrong setting. (GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.
MDA/2011/097 28 September 2011 Some EnRhythm® and EnRhythm MRI™ implantable pacemakers - software update may trigger unexpected ERI. (Medtronic) a software update of the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI.
MDA/2011/096 27 September 2011 Reusable laryngoscope handles - inquest found contaminated device caused patient's death.   (All models and manufacturers) MHRA received a report of an inquest that found a patient died after a laryngoscope handle had not been decontaminated appropriately between each patient use.
MDA/2011/079 13 July 2011 Implantable pulse generators (IPGs) neurostimulators - confirm actions from field safety notice. (St Jude Medical) manufacturer not received sufficient confirmation of action after a field safety notice was sent out on the faulty battery components that could result loss in ability to communicate with the programmer or recharge in some IPGs.
MDA/2011/075 6 July 2011 Headrest attachment to operating tables - confirm actions after receipt of field safety notice. (Maquet Ltd) manufacturer has not received sufficient confirmation of actions after it sent a field safety notice on safe use of connection fixture 1002.65A0 and 1002.65S0.
MDA/2011/073 29 June 2011 Implantable cardioverter defibrillator (ICD) - risks with pacing inhibition. (Sorin CRM) pacing inhibition causes risk of bradycardia / syncope; also potential association between pacing inhibition and ventricular oversensing if 'PhD' is 'on' and the device is connected to high polarisation defibrillation leads
MDA/2011/068 15 June 2011 Needle-free intravenous connectors - incompatibility and risk of infection. (All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients.
MDA/2011/067 12 June 2011 SQ-RX® pulse generator, model 1010 - subcutaneous implantable cardioverter defibrillator (S-ICD) - battery might die early.   (Cameron Health) risk of premature depletion of battery before the 3 nomina months.
MDA/2011/066 8 June 2011 Plum A+ infusion pumps - potential failure. (Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment.
MDA/2011/060 2 June 2011 Dual Chamber Pacemakers - confirm actions with manufacturer after receipt of field safety notices. (Medtronic Ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (Reference: FA507).
MDA/2011/056 25 May 2011 Pacemaker - Reply and Esprit models interrogated with programmer containing software version 2.24 - software anomaly.   (Sorin CRM) field safety notice published after a programmer software anomaly was found that could lead to cardiac instability or unnecessary explant due to inconsistent battery information.
MDA/2011/051 19 May 2011 Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - risk of inappropriate shocks. (Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949.
MDA/2011/026 15 March 2011 Ligasure blunt tip laparoscopic sealer/divider - potential risk of serious thermal burns. (Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue.
MDA/2011/017 16 February 2011

All types, makes and models of breast implants - potential increased risk of anaplastic large cell lymphoma (ALCL).   (All) uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast - none reported in the UK.

(Note: The recommendations in this Medical Device Alert (MDA) have been replaced with new advice given in MDA-2018-027)

MDA/2010/094 14 December 2010 Umbilical cord clamps - close the clamp by squeezing it at the grips until you hear a click. (All) incorrect placement of the clamp on the umbilical cord has lead to improper seal and blood loss in a small number of cases, which can be fatal
MDA/2010/078 4 October 2010 Silicone gel filled breast implants - advice on clinical management of women with implants. (Poly Implant Prothese (PIP)) advice for implanting surgeons to identify women with PIP implants and advise them that further testing will be carried out.
MDA/2010/073 20 September 2010 Intravenous (IV) extension sets with multiple ports - risk of backtracking.   (All brands) risk of back-tracking when an IV line has multiple access ports, which can lead to under-infusion or bolus delivery of IV drugs.
MDA/2010/070 9 September 2010 LIFEPAK 20/20e defibrillator/monitor - component failures. (Medtronic/Physio-Control) component failures affect AC (mains) and/or DC (battery) operating power, which may lead to the defibrillator not able to deliver therapy.
MDA/2010/064 11 August 2010 Novabel® dermal filler - practitioners should stop use and return all unused products. (Merz Pharmaceuticals GmbH) manufacturer has received reports of adverse reactions to the filler. 
MDA/2010/054 28 June 2010 Fetal monitor/cardiotocograph (CTG) - adverse outcomes still reported. (All) adverse outcomes are still reported when CTG traces appear normal - this replaces alert SN 2002(23) issued August 2002.
MDA/2010/050 15 June 2010 Implantable vagus nerve stimulators (VNS) - follow manufacturer's latest field safety notices. (Cyberonics VNS Therapy) device can have premature battery depletion (models 103 and 104), inaccurate battery life projection (models 103, 104 and 250), loss of therapy (all models) and painful, erratic or atypical stimulation (all models).
MDA/2010/039 12 May 2010 Aquarius haemofiltration machines - follow instructions carefully. (Edwards Lifesciences Ltd, supplied by Baxter Healthcare) reports that the wheels break if not used properly, which could cause the machine to fall over to cause injury and interrupt therapy
MDA/2010/036 6 May 2010 All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators - inadequate ventilation. (All) harm of inadequate patient ventilation and oxygenation could have been avoided if an alternative means of ventilation had been used earlier.
MDA/2010/025 31 March 2010 All models and lot numbers of silicone gel filled breast implants - unapproved composition of silicone gel.   (Poly Implant Prothese (PIP)) French medical device regulatory authority (AFSSAPS) found the composition of silicone gel for most breast implants have been different to the one approved since 2001. 
MDA/2010/023 23 March 2010 Intracranial stent - don't use to treat intracranial aneurysms without embolisation coils. (Balt Extrusion) potential for patient death if you use any SILK artery reconstruction device to treat intracranial aneurysms without embolisation coils.
MDA/2010/020 10 March 2010 Hansen-type coloured dialysis fluid line connectors - incorrectly configured.  (All manufacturers) potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) which results in significantly less efficient dialysis.
MDA/2010/012 10 February 2010 Teligen and Cognis defibrillators - risks for devices implanted subpectorally.   (Boston Scientific) specific models of defibrillators implanted subpectorally have a risk of loss of shock therapy, inappropriate shock therapy, loss of pacing therapy or loss of anti-tachycardia pacing.
MDA/2010/008 21 January 2010 Intraocular lens (IOL) - hydrophilic acrylic - opacification. (intraocular lens (IOL) - hydrophilic acrylic) opacification of intraocular lens (IOLs) may occur following intracameral use of alteplase.
MDA/2010/006 18 January 2010 Devices used for endometrial ablation - clinicians should confirm patients have no evidence of uterine perforation or false passage. (All makes and models) MHRA receives reports of uterine wall injury, wall perforation or the creation of a false passage after use of endometrial ablation devices.
MDA/2010/002 05 January 2010

All types of bed mattresses - contamination through damaged mattresses or covers. (All types of bed mattresses) body or other fluids can pass through and contaminate inner core of damaged mattresses or covers and cause cross-infection if used.

MDA/2009/080 9 December 2009 Ultrasound transducer - review advice by the Advisory Committee on Dangerous Pathogens (ACDP). (All manufacturers) Potential onward transmission of abnormal prion protein when ultrasound transducer probes with internal lumen during transrectal prostate biopsies on men at risk of vCJD.
MDA/2009/076 24 November 2009 Aquarius haemofiltration machine - manufacturer has updated their actions for software problems. (Edwards Lifesciences Ltd) the manufacturer has updated their corrective actions for software problems with haemofiltration machines
MDA/2009/038 10 June 2009 Kappa 600/700/900 series and Sigma 100/200/300 series pacemakers - potential unexpected failure. (Medtronic Ltd) certain Kappa® and Sigma® series pacemakers may suddenly fail, which may cause bradycardia symptoms (fainting or light headedness) or serious injury/death in patients dependent on a pacemaker.
MDA/2009/032 29 April 2009 Bioprosthetic heart valves - follow manufacturer's instructions to prepare implants before use. (All makes and models) premature failure of bioprosthetic heart valves if they are not properly washed or rinsed before implantation.
MDA/2009/028 21 April 2009 Goldmann applanation tonometer prism - use recommended disinfectants. (Haag-Streit Ag) inappropriate disinfectants may cause damage the tonometer prism, which could result in corneal irritation.
MDA/2009/023 2 April 2009 Zenith abdominal aortic aneurysm (AAA) endovascular grafts and associated H&L-B One-Shot - serious injury or death of the patient during graft deployment. (Cook Medical Incorporated) potential for serious injury or death of the patient due to the difficulty or inability to release the suprarenal stent during graft deployment.
MDA/2009/014 23 February 2009 UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems - identify affected devices and remove from service immediately. (MECALL Srl) an X-ray tube head has fallen onto the table after the support cable and the backup ‘safety device’ failed at the same time.
MDA/2008/087 18 December 2008 SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 implantable drug pumps - scan patients with these. (Medtronic) Risk of delays in the resumption of drug infusion and in logging of motor stall events after MRI scans. 
MDA/2008/068 22 September 2008 Implantable cardioverter defibrillators (ICDs) - disable all high voltage shock therapies before you remove ICD. (All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs).
MDA/2008/065 11 September 2008 N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders neurostimulator programmers - error in programmer software.   (Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status.
MDA/2008/046 1 July 2008 Lancing devices (used in pharmacy settings) - risk of transmission of blood borne infections. (All brands) there is a risk of transmission of blood borne infections if a lancing device is used for testing between multiple patients contrary to the manufacturer's instructions for use.
MDA/2008/038 9 June 2008 Implantable drug pumps for intrathecal therapy - risk of temporary or permanent neurological impairment. (All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment.
MDA/2007/095 6 December 2007 Medical device alert: external temporary cardiac pacemaker (bedside model 4170 serial numbers 1 - 998) - return these to manufacturer and ensure rapid pace switch is off before you shut the device down. (APC Medical Ltd) the manufacturer has found potential for rapid pacing while switching off this temporary pacemaker.
MDA/2007/078 9 October 2007 Medical device alert: Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - reports of lead conductor fracture. (Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the UK including an investigation into a fatality.
MDA/2007/045 4 June 2007 Optima XL stubby handle and laryngoscope handle - delays to intubation.   (Timesco of London Ltd.) possibility that poor contact between Timesco stubby handles and Timesco laryngoscope blades (models: 3000.308.10 and 3000.308.10T) may result in the bulb not being lit with subsequent delays to intubation.
MDA/2007/042 23 May 2007 External pacemakers and temporary cardiac pacing leads - concerns that insecure systems still being used. (All ) concerns that some insecure adaptor systems are being used to connect temporary pacing leads to external pacemakers.
MDA/2007/040 23 May 2007 Primus anaesthetic workstation - ensure the backup oxygen cylinder’s non-interchangeable screw threaded (NIST) fitting is connected to the appropriate oxygen inlet. (Draeger Medical UK Ltd) report of an incorrect connection of the backup oxygen cylinder, which would prevent backup oxygen supply if the oxygen pipeline failed.  
MDA/2007/031 23 April 2007 Patient hoists and slings - ensure you follow manufacturer's instructions for use and that you carry out risk assessments. (All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities.
MDA/2007/023 15 March 2007 Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families - identify patients with these implants. (Boston Scientific Ltd.) patients may experience extended charge times in the middle-of-life phase of the device, which could lead to a delay in shock delivery; also replacement and end of life indicators may display earlier than expected.
MDA/2007/009 1 February 2007 Bed rails and grab handles - incorrect use can cause death. (All) bed rails can successfully prevent falls, but if used incorrectly they can result in deaths of bed occupants by asphyxiation due to entrapment.
MDA/2006/066 6 December 2006 Lancing devices used in nursing homes and care homes - correction to list of disposable single-use lancing devices.   (All) MHRA continues to receive reports of hepatitis B outbreaks in nursing homes and care homes, which is linked with single-use lancing devices being used on multiple patients.
MDA/2006/065 23 November 2006 Medical pacemakers (Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376) - perform a manual measured data reading in follow-ups. (St Jude Medical UK Ltd) a programmer software anomaly can occur when these devices are used together, which can cause inaccurate display of battery voltage, battery longevity and elective replacement indicator (ERI) status.   
MDA/2006/055 21 September 2006 Hand pieces used with oral / maxillofacial surgery drills - ensure maintenance procedures are in place to prevent drill from overheating. (General) significant increase in the number of reports from patients receiving oral burns from hand pieces used with overheated drills mostly due to lack of appropriate maintenance.
MDA/2006/038 13 July 2006 Implantable pacemaker and implantable defibrillator families (INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR2, VENTAK PRIZM 2 VITALITY, VITALITY 2) – recall.   (Guidant) recall of subset of implantable pacemakers and defibrillators due to component failure that may lead to malfunction or premature depletion of battery.
MDA/2006/022 22 March 2006 MiniCap peritoneal dialysis disconnect cap with povidone-iodine - monitor thyroid function in patients with small fill volumes. (Baxter Healthcare Ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism.
MDA/2006/019 16 March 2006 All cochlear implants - update on immunisation recommendations. (All) risk of pneumococcal meningitis in cochlear implant patients.
MDA/2005/072 21 December 2005 Sigma® implantable pacemakers - advise patients to contact their follow-up clinic immediately if they experience a return of symptoms. (Medtronic) failure of interconnecting wires may cause loss of pacing output from atrial and or ventricular ports, premature depletion of battery, intermittent or total loss of telemetry, undersensing, high lead impedance values, loss of rate response, device reset to manufacturer's default settings.
MDA/2005/070 19 December 2005 INSIGNIA and NEXUS implantable pacemakers - recall. (Guidant) component failure.
MDA/2005/067 8 December 2005 INSIGNIA and NEXUS implantable pacemakers - consider replacement of elective device if there are one or more malfunctions. (Guidant) device may have intermittent or permanent loss of pacing output without warning, intermittent permanent loss of telemetry, reversion to ventricular inhibited pacing (VVI), and/or reset warning message upon interrogation.
MDA/2005/045 25 July 2005 Implantable cardioverter defibrillators (ICDs) - ensure you have updated software for models 3510 and 3510+ ICD programmers. (St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. 
MDA/2005/038 27 June 2005 CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds) - follow up with patients within every 3 months. (Guidant) potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock.
MDA/2005/037 27 June 2005 VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) - ensure follow ups are within every 3 months. (Guidant) potential loss of cardioversion, defibrillation or pacing therapy of model 1861 due to diversion of high voltage shock.
MDA/2004/047 27 September 2004 Trilucent (soya bean oil filled) breast implants - update on actions from previous risks.   (Lipomatrix Inc) conclusions of research after device was recalled for risks of break down of filler and update of HN2000(05).
MDA/2004/045 9 September 2004 Implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx - identify affected patients. (Medtronic) extended charge times and inability to deliver therapy for a subset of the above devices when battery voltages are close to elective replacement indicator (ERI).
MDA/2004/019 26 April 2004 Implantable defibrillators - follow up with patients given these devices. (Medtronic) Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277; potential battery defect; possible rapid depletion.
MDA/2003/044 2 December 2003 Transilluminators used with neonates - ensure you follow the instructions and that the device can be used with neonates. (All) use of an inappropriate light source for transillumination can result in burns
MDA/2003/037 27 October 2003 Electrosurgical (diathermy) accessories - ensure procedures are in place to check all electrosurgical accessories regularly. (All) malfunction and failure during use.
MDA/2003/035 22 October 2003 SynchroMed® implantable drug pump - consider changing diamorphine for another medicine. (Medtronic) diamorphine solution is incompatible with the implantable drug pump.
MDA/2003/008 27 March 2003 External pacemakers - sudden increase in pacing rate and change of mode. (APC Medical Ltd) the pacing rate for models E4162, E4164, E4165 and E4166 may increase by 20 pulses per minute and change in pacing mode in some cases.


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