Medical Device Alerts - MDA's - 2013 - 2015

The following Medical Device Alerts were issued between 2013-2015

2013 - 2015

Reference  Date of Issue Title 
MDA/2015/039 21 December 2015 GlucoMen LX Sensor test strips used to monitor blood glucose levels - risk of over-estimation. Distributed by Menarini Diagnostics UK - if test strips have been exposed to high humidity, the results can be falsely high.
MDA/2015/038 9 December 2015 Cardiac Resynchronization Therapy Pacing (CRT-P) - risk of loss of pacing therapy. Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy.
MDA/2015/037 18 November 2015 Sapphire multi-therapy and epidural pumps – update to instructions for use. Manufactured by Q Core Medical, distributed in the UK by Hospira – update to instructions for use regarding fluctuations in flow rate accuracy after potential over-infusion of epidural infusions
MDA/2015/036 15 October 2015 Testicular implants and inflatable vaginal stents – temporary suspension of the CE certificate. Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda.
MDA/2015/035 29 September 2015 Enteral syringe pumps P500, P700 and P900 - recall due to invalid CE marking. Manufactured by Medicina Ltd - the safety and performance of these devices have not been properly evaluated.
MDA/2015/034 25 September 2015 Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda - temporary suspension of the CE certificate. Suspension due to particles found on some devices
MDA/2015/033 26 August 2015

Sterile electrosurgical forceps and electrodes - Some devices may not be sterile. (Zethon Limited and Ross Electro Medical Limited) Recall of specific batches.

MDA/2015/032 25 August 2015 Charging base for surgical hair clippers - recall of specific lots due to risk of fire. (Medline Industries) Risk of fire in oxygen-rich environment if defective charging base overheats.
MDA/2015/031 18 August 2015 Accu-Chek mobile meter and Accu-Chek mobile test cassette - risk of falsely high readings if testing procedure is not followed. (Roche Diabetes Care) Home-use blood glucose monitoring system - if patients do not follow specific testing procedure they may take insulin when they don't need it.
MDA/2015/030 5 August 2015 Shiley™ neonatal and paediatric tracheostomy tubes - recall of specific affected products. (Medtronic - previously Covidien) Shiley N NEF/NCF/PEF/PCF/PELF/PLCF tracheostomy tubes are being recalled, as some patients experience breathing difficulties when changing to these earlier models of tube from current tubes.
MDA/2015/029 4 August 2015 All Accu-Chek® Insight insulin pumps - risk of hyperglycaemia from rapid pump battery depletion or unexpected shut down. (Roche Diabetes Care) Advice from manufacturer to users about the correct battery specification and appropriate pump settings.
MDA/2015/028 4 August 2015 Automatically retracting safety syringes including insulin syringes by Medicina Ltd - recall. Risk of needle stick injury as they may not automatically retract and the shelf life stated on the devices is incorrect, compromising its sterility.
MDA/2015/027 23 July 2015 Steel cannula infusion sets - risk of needle breaking in use. (Unomedical a/s) May cause leakage of medication and require surgical intervention to remove the needle.
MDA/2015/026 21 July 2015 Haemodialysis CRIT-LINE® blood chamber with product code CL10021021 - recall due to risk of blood loss. (Fresenius USA Manufacturing Inc. / Hemametrics) Recall of all lots due to risk of blood loss caused by leakage at the blood chamber connection.
MDA/2015/025 6 July 2015 TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer - risk of serious burn. (CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date.
MDA/2015/024 25 June 2015 Metal-on-metal (MoM) hip replacements - guidance on implantation and patient management. (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups.
MDA/2015/022 11 June 2015 Heater-cooler devices used in cardiac surgery - risk of infection with Mycobacterium species. (All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines.
MDA/2015/021 21 May 2015 Reissue - Philips ventilators BiPAP autoSV, BiPAP autoSV Advanced, OmniLab Advanced, OmniLab Advanced + and HeartPAP devices. (Philips Healthcare) Philips recommend you check these devices for risks after an alert was issued about ResMed's ventilators with Adaptive ServoVentilation (ASV) mode.
MDA/2015/020 13 May 2015 Specific ResMed ventilators with Adaptive ServoVentilation (ASV) - increased risk of cardiovascular death in patients who have a specific heart condition. (ResMed Ltd) Physicians should assess all patients currently being treated with ASV mode for symptomatic chronic heart failure and if necessary undertake an assessment of LVEF.
MDA/2015/018 21 April 2015 All posture or safety belts fitted to supportive seating, wheelchairs, hoists and bathroom equipment - risk of serious injury or death. Risk of serious injury or death of the person using a posture or safety belt that isn't fitted or adjusted properly.
MDA/2015/017 10 April 2015 Dental panoramic X-ray systems CS 8100 and CS 8100 3D - risk of injury if dental head unit drops. (Carestream Health) Risk of injury to patient and/or user if the dental head drops unexpectedly.
MDA/2015/016 2 April 2015 All Mackworth Healthcare Ltd slings fitted with a DOSEC® clip - manufacturer guidance update. (Mackworth Healthcare Ltd) Ensure that all relevant members of staff are aware of the updated guidance.
MDA/2015/015 1 April 2015 Hudson RCI© humidifier adaptors and Aquapak sterile water with humidifier adaptors - risk of inhaling plastic pieces. (Teleflex Medical) Some packages contain pieces of plastic that could get into the gas flow path and enter the lungs.
MDA/2015/014 26 March 2015 V-Green spinal needle 25G pack - incorrect size of introducer needle supplied in the pack. (Vygon) Risk of delay in treatment or repeat of procedure due to incorrect size of introducer needle supplied in the pack.
MDA/2015/013 23 March 2015 Enteral feeding devices and accessories, syringes, plasters, dressings and rectal straws - invalid CE markings. (Medicina LTD) Devices are being recalled because the CE marking is invalid and there is a risk of infection from using the gastrostomy button feeding kits
MDA/2015/011 16 March 2015 Satella-X ceiling suspended skull x-ray unit - tube and detector arm may drop to the floor. (NRT) Risk of injury to patient and/or user due to the tube and detector arm dropping to the floor.
MDA/2015/010 12 March 2015 PadPro and R2 multifunction electrodes - risk of delay to shock. (Conmed) Risk of delay to shock as specific electrodes manufactured by Conmed are now incompatible with some models of Philips defibrillators.
MDA/2015/009 5 March 2015 Defibrillation electrodes for children - electrodes older than 2 years may malfunction. (Leonhard Lang) Electrodes older than 2 years may malfunction and this could delay urgent treatment.
MDA/2015/008 3 March 2015 Breathing system components - risk of interruption to anaesthesia and/or ventilation. (Inmed, supplied by Teleflex) Risks due to cracks in the corrugated flex tube - manufacturer is recalling affected devices.
MDA/2015/007 25 February 2015 Recall of Vyclic Colour 3-way stopcock 2FL/1M: risk of sterility being affected. (Vygon) The paper side of the primary packaging could be punctured compromising sterility, manufacturer is recalling the devices.
MDA/2015/006 20 February 2015 Consent decree for medical devices supplied by Atrium Medical (Maquet). (Atrium Medical subsidiary of Maquet) Guidance for healthcare professionals who have received a Food and Drug Administration (FDA) consent decree from Maquet about its subsidiary Atrium Medical.
MDA/2015/004R 6 February 2015 Reissue: endobronchial tubes - potential failure to ventilate the patient if Cobb connector detaches from main connector. Reissued – ‘Problem’ section removed: (Teleflex Medical) Could lead to hypoxia and hypercarbia if not immediately detected and corrected.
MDA/2015/004 4 February 2015 Endobronchial tubes - potential failure to ventilate the patient if Cobb connector detaches from main connector. (Teleflex Medical) Could lead to hypoxia and hypercarbia if not immediately detected and corrected.
MDA/2015/003 21 January 2015 Renasys™ negative pressure wound therapy range - risk of maceration, infection, loss of negative pressure or unrecognised bleeding in wounds. (Smith & Nephew Healthcare Limited) Risk of maceration, infection, loss of negative pressure or unrecognised bleeding in wounds if there is a blockage in the vacuum system of affected devices.
MDA/2015/002 20 January 2015 HomeChoice and HomeChoice PRO automated peritoneal dialysis system - added to and updated warnings and cautions. (Baxter Healthcare Ltd) Various changes to the ‘Patient At-Home Guide’ warnings relate to both identifying patient fluid retention and the general safe operation of the product.
MDA/2015/001 16 January 2015 Insulin infusion pump - risk of hyperglycaemia or hypoglycaemia. (Roche Diagnostics Ltd) Risk of hyperglycaemia or hypoglycaemia if the pump’s power is interrupted.
MDA/2014/048 18 December 2014

IW900-series infant warmers - risk of serious injury to the infant in the warmer. (Fisher and Paykel Healthcare) Heater head may partially detach due to manufacturing fault if the nut securing the heater head breaks.

MDA/2014/047 17 December 2014 Autopen insulin pen injection devices - risk of hyperglycaemia. (Owen Mumford Ltd) Affected devices may have a mechanical fault which could cause the dose selector to revert to zero, which results in the devices not delivering the correct dose of insulin.
MDA/2014/046 8 December 2014 Toshiba ultrasound transducers - counterfeit ultrasound transducers supplied to 2 hospitals. Users should check Toshiba ultrasound transducers not supplied direct from Toshiba Medical Systems UK
MDA/2014/045R 5 December 2014 Multicath Expert 5 Lumen (9.5FG/16cm) - risk of incorrect placement of catheter. (Vygon) Due to a manufacturing problem the catheter tip may not reach the desired position during placement and some may have 4 lumens instead of 5
MDA/2014/044 26 November 2014 Mains power lead used with Omnifuse syringe pumps (part number 0151-0651) - quarantine affected leads. (Smiths Medical International Ltd. - all models) incorrect design of the mains lead causes a risk of interruption or delay in therapy
MDA/2014/042 03 November 2014 Hudson RCI© nebulizer adaptors and Aquapak sterile water with nebulizer adaptors - identify and quarantine affected devices. (Teleflex Medical) Risk of the packaging not being sealed properly
MDA/2014/041 21 October 2014 Babytherm infant warmers and open infant care units for newborns - identify affected devices and read latest information. (Draeger Medical) Risk of baby falling out of the device.
MDA/2014/040 9 October 2014 LIFEPAK® 1000 defibrillator - risk of failure to deliver a shock. (Physio-Control) Due to unexpected shut down of the defibrillator caused by a battery with very low charge.
MDA/2014/039 7 October 2014 TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D) - identify patients affected recently. (Boston Scientific) Rapid battery depletion leads to risk of loss of therapy.
MDA/2014/037 26 September 2014 All medical devices - ensure system is in place to distribute field safety notices (FSNs). (All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs).
MDA/2014/035 16 September 2014 Ellipse™ VR/DR implantable cardioverter defibrillators (ICDs) - potential failure mode. (St Jude Medical) These defibrillators can delay or reduce the therapy that can be delivered by the ICD.

11 July 2014

Procedure packs containing various central venous catheters - risk of incorrect lumen selection. (Arrow International - a division of Teleflex) Issued as an update to MDA/2014/022.
MDA/2014/027 10 July 2014

Breast implants - report cases of anaplastic large cell lymphoma (ALCL). (All types, makes and models) Report cases in women who have breast implants or who have had them removed.

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

MDA/2014/024 25 June 2014 HeartStart MRx defibrillators/monitors - risk of delay in delivering CPR. (Philips) When HeartStart MRx is used with Q-CPR meter in defibrillation mode, meter may incorrectly display ‘Do Not Touch the Patient’ icon.
MDA/2014/022 12 June 2014 Central venous catheters - extension lumen may have the wrong exit and size printed on it. (Arrow International - a division of Teleflex) Use the Arrow’s hub colour coding as a guide, not what is printed on the lumen.
MDA/2014/020 4 June 2014 Heated humidifiers used in combination with heated-wire breathing systems - risk of oxygen-fuelled fire. (Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used.
MDA/2014/019 29 May 2014 Paradigm ambulatory insulin infusion pumps - risk of hypoglycaemia. (Medtronic) Risk due to incorrect selection and delivery of bolus amount.
MDA/2014/018 28 May 2014 Unicondylar sled knee prosthesis - risk of early wear. (Waldemar Link GmbH & Company.KG) Consider annual review of patients for up to 5 years after implantation, including X-rays to detect progression of bearing wear.
MDA/2014/015 14 May 2014 All Pace Medical Inc temporary pacemakers and pacing system analysers (PSAs) – CE marking suspended. (Pace Medical Inc) CE-marking suspended due to quality system failings. 
MDA/2014/014 29 April 2014 Samaritan® public access defibrillator - may miscalculate the cardiopulmonary resuscitation (CPR) rate. (HeartSine Technologies) Rescuer may be incorrectly advised by the device to ‘Push Slower’ when CPR rate is actually at an acceptable level.
MDA/2014/011 24 March 2014 Powered wheelchairs - risk of injury. (Pride Mobility Products Ltd) Risk of injury should powered wheelchairs be secured into vehicles incorrectly.
MDA/2014/008 10 March 2014 Insulin infusion pump - risk of delay in treatment. (Roche Diagnostics Ltd) Increased risk that the vibration alarm will not work as a result of a changed component.
MDA/2014/006 26 February 2014 CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator - risk of burns. (Integra Lifesciences) Blue COAG button on the CUSA® Excel CEM™ nosecone could stick in the ‘activated’ position.
MDA/2014/005 21 February 2014 Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 - risk of injury. (Carestream Health) Risk of injury if joint between scissor arm and bracket fails.
MDA/2014/004 24 January 2014 Counterfeit or non-CE marked dental medical devices. (All products) Could fail during use with a risk of injury to patient and user.
MDA/2014/003 17 January 2014 Plastipak 50ml Luer Lok single-use syringes - risk of delay or interruption to treatment. (BD Medical) Occlusion alarms triggering due to an increased plunger movement force.
MDA/2013/086 19 December 2013 Pressure reducing air mattresses – silicone oil may leak. (Hill-Rom) Oil may leak out of the pressure sensor of the mattress and spill onto the floor resulting in slips and injury
MDA/2013/085 19 December 2013 GemStar docking station for use with specific GemStar infusion pumps - potential for delay in infusion therapy. (Hospira) May fail to power up or configuration could generate an error code, stopping a running infusion.
MDA/2013/084 19 December 2013 Implantable pacemakers - residual longevity overestimated. (Sorin) Difference between predicted and actual pacemaker battery depletion characteristics.
MDA/2013/078 4 November 2013 Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser - CE marking withdrawn. (Hospira) Use an alternative pump, where available.
MDA/2013/074 10 October 2013 BD Neoflon IV cannula - risk of delay in treatment. (Becton Dickinson) Due to increased risk of the catheter buckling during initial puncture of skin.
MDA/2013/066 15 August 2013 HeartStart XL defibrillator/monitor - battery life and capacity test interval reduced. (Philips) Battery life reduced from 1.5 years to 1 year and capacity test interval reduced from 6 months to 3 months.
MDA/2013/060 1 August 2013 Wheeled and non-wheeled walking frames (all models) - potential for detachment of the wheels and/or inadequately tightened screws. (Patterson Medical) May cause the user to fall.
MDA/2013/055R 24 July 2013 Days walking stick (Model 404) - handle can crack. (Patterson Medical Ltd) May cause the user to fall.
MDA/2013/053 18 July 2013 Intra-oral dental X-ray units: IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510 – wall mount bracket may fail. (Trophy (now owned by Carestream Health)) Risk of injury from falling unit after failure of the wall mount bracket
MDA/2013/052 11 July 2013 HeartStart MRx Monitor/Defibrillator –possible failure to deliver defibrillation therapy . (Philips Healthcare) May fail to deliver defibrillation therapy in either “Manual Defib”, “AED” or “Sync Cardioversion” mode.
MDA/2013/045R 10 July 2013

Biplane cardiovascular X-ray system (Floor Mounted) - risk of interruption in treatment/procedure.  (Philips) Motorised geometry control system will reboot if users attempt simultaneous powered and manual movement of the C-arm.

MDA/2013/045 24 June 2013 Biplane cardiovascular X-ray system - risk of interruption in treatment/procedure.  (Philips) Table will reboot if users attempt a powered and manual movement at the same time.
MDA/2013/044 20 June 2013 Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS - incorrectly etched screw size. (Synthes GmbH) Could lead to clinical complications including dural injury, bleeding and failure of fracture fixation.
MDA/2013/042 19 June 2013 Implantable drug pumps and accessories - risk of drug under- or overdose. (Medtronic) 4 field safety notices concerning these products.
MDA/2013/037 3 June 2013 SERVO-i ventilator system battery modules - risk of early or unexpected loss of ventilation. (Maquet) Due to certain battery modules having shorter than specified run time.
MDA/2013/036 31 May 2013 MICRO-PACE REF 4580 - return to market. (Pace Medical and distributed in UK by APC Cardiovascular) Ensure continued, heightened vigilance in monitoring.
MDA/2013/035 17 May 2013 Paradigm ambulatory insulin infusion pumps - risk of compromised insulin therapy. (Medtronic) May lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose).
MDA/2013/032 9 May 2013 Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - risk of inadequate external pacing. (All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death.
MDA/2013/028 2 May 2013 Retrievable inferior vena cava (IVC) filters - serious complications associated with attempted IVC filter retrieval . (All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model.
MDA/2013/020 27 March 2013 Acrobat Swing (AC Swing) arm - risk of injury from detachment of the swing arm. (Ondal) After approximately 7 years of use, the plastic spigot joint of swing arm can fail through fatigue.
MDA/2013/019 27 March 2013 Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces. (All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device.
MDA/2013/016 26 March 2013 GemStar infusion system - risk of over-infusion, low infusion rates or an interruption of infusion. (Hospira) Due to pump faults.

19 March 2013

Mitral Valve Repair System: MitraClip Clip Delivery System - risk of death or serious harm. (Finsbury Orthopaedics Ltd) Risk if the Actuator Knob of the Clip Delivery System (CDS) is turned in wrong direction.
MDA/2013/010 12 March 2013 ADEPT® 12/14 modular head hip components - higher than expected revision rate.  (Finsbury Orthopaedics Ltd) Do not implant ADEPT® 12/14 modular head devices.
MDA/2013/007 21 February 2013 Isoline implantable cardioverter defibrillator (ICD) leads - risk of inappropriate shocking, pacing inhibition or shocking inhibition. (Hospira) Due to insulation abrasion.
MDA/2013/006 20 February 2013 Infusion pumps: Plum A+ and A+3 family of infusers - risk of interruption in therapy. (Hospira) If pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop
MDA/2013/004 6 February 2013 Infusion pumps: Plum A+ single channel infuser systems - risk of interruption in therapy. (Hospira) Clinical staff failing to hear an audible alarm
MDA/2013/003 22 January 2013 Ambulatory insulin infusion pumps - software problem. (Animas) From 1 January 2016 the pumps will not deliver insulin and will generate a call service alarm
MDA/2013/001 10 Janaury 2013 External pacemaker: MICRO-PACE REF 4580 - temporarily withdrawn from sale. (Pace Medical and distributed in the UK by APC Cardiovascular) Potential for loss of ventricular output or sensing failure.


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