2018 & 2019
| Reference | Date of Issue | Title |
|---|---|---|
| MDA-2019-046 | 19 December 2019 | Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury |
| MDA-2019-045 | 18 December 2019 | ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring |
| MDA-2019-044 | 12 December 2019 | BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking |
| MDA-2019-043 | 11 December 2019 | Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 |
| MDA-2019-042 | 05 December 2019 | Natus gold cup electrodes and snap electrode leads – risk of electric shock |
| MDA-2019-041 | 04 December 2019 | Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use. |
| MDA-2019-040 | 27 November 2019 | Alaris Gateway Workstation and Alaris Gateway Workstation Web Browser User Interface |
| MDA-2019-039 | 31 October 2019 | Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart |
| MDA-2019-038 | 29 October 2019 | Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released |
| MDA-2019-037 | 10 October 2019 | Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment |
| MDA-2019-036 | 10 October 2019 | Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use |
| MDA-2019-035 | 9 October 2019 | Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices |
| MDA-2019-034 | 9 October 2019 | Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) |
| MDA-2019-033 | 8 October 2019 | Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit |
| MDA-2019-032 | 03 October 2019 | Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use |
| MDA-2019-031 | 30 September 2019 | Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) |
| MDA-2019-030 | 18 September 2019 | All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress |
| MDA-2019-029 | 12 September 2019 | Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion |
| MDA-2019-028 | 27 August 2019 | Microneedling pens: Dermapen 3 and Dermapen Cryo sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection |
| MDA-2019-027 | 25 July 2019 | Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate |
| MDA-2019-026 | 24 July 2019 | Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes |
| MDA-2019-025 | 02 July 2019 | IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low |
| MDA-2019-024 | 26 June 2019 | BBraun Dialog+ SW versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) haemodialysis machines – upgrade of software required |
| MDA-2019-023 | 04 June 2019 | Recommendations for ongoing use of paclitaxel drug coated balloons (DCBs) and implantable drug eluting stents (DESs) in the treatment of patients with peripheral artery disease (PAD) |
| MDA-2019-022 | 30 May 2019 | Aisys & Aisys CS2 anaesthesia devices with Et Control option & software versions 11, 11SP01 & 11SP02 – risk of patient awareness due to inadequate anaesthesia |
| MDA-2019-021 | 01 May 2019 | Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance (Note: This Medical Device Alert (MDA) updates guidance previously given in MDA-2019-002 issued 25 January 2019.) |
| MDA-2019-020 | 01 May 2019 | Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance (Note: This Medical Device Alert (MDA) updates guidance previously given in MDA-2019-002 issued 25 January 2019.) |
| MDA-2019-019 | 25 April 2019 | Ethicon Curved Intraluminal Staplers – risk of failure of staple lines |
| MDA-2019-018 | 29 March 2019 | Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment |
| MDA-2019-017 | 20 March 2019 | Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting |
| MDA-2019-016 | 19 March 2019 | enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer |
| MDA-2019-015 | 8 March 2019 | enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device * Please note - This has been replaced by MDA-2019-016 |
| MDA-2019-014 | 07 March 2019 | All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed |
| MDA-2019-013 | 04 March 2019 | All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues |
| MDA-2019-012 | 28 February 2019 | Potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps |
| MDA-2019-011 | 27 February 2019 | Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 – risk of loss of patient monitoring |
| MDA-2019-010 | 20 February 2019 | Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy |
| MDA-2019-009 | 19 February 2019 | Accu-Chek® Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons |
| MDA-2019-008 | 13 February 2019 | Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy |
| MDA-2019-007 | 13 February 2019 | Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze |
| MDA-006-2019 | 08 February 2019 | Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening |
| MDA-2019-005 | 30 January 2019 | Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination |
| MDA-2019-004 | 30 January 2019 | Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts WITHOUT a scale |
| MDA-2019-003 | 29 January 2019 | FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive |
| MDA-2019-002 | 25 January 2019 | Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance
This MDA has been updated- please see MDA-2019-021 for updated guidance |
| MDA-2019-001 | 17 January 2019 | Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 (Service Pack) – Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension |
| MDA-2018-037 | 21 December 2018 | Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO – Risk of total loss of patient ventilation. |
| MDA-2018-036 | 29 November 2018 | Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power. |
| MDA-2018-035 | 14 November 2018 | All T34 ambulatory syringe pumps – update concerning battery information |
| MDA-2018-034 | 14 November 2018 | Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging. Additional Devices Affected - Please see MDA-2019-012 |
| MDA-2018-033 | 08 October 2018 | CoaguChek Test Strips for Point of Care and Home Use – risk of false high results |
| MDA-2018-032 | 24 September 2018 | Various trauma guide wires – risk of infection due to packaging failure |
| MDA-2018-031 | 19 September 2018 | SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018: risk of batteries overheating or igniting |
| MDA-2018-030 | 19 September 2018 | Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation |
| MDA-2018-029 | 13 September 2018 | BenchMark Automated Slide Stainer series – FLO LOK III Reagent Dispenser Issue for IHC and ISH kits including INFORM HPV III Family 16 Probe (B). |
| MDA-2018-028 | 01 August 2018 | Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection |
| MDA-2018-027 | 26 July 2018 | Breast implants, all types, makes and models – Continue to report suspected cases of Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL) |
| MDA-2018-026 | 23 July 2018 | First generation JOURNEY BCS Knee System– Higher than expected risk of revision |
| MDA-2018-025R | 12 July 2018 | Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use |
| MDA-2018-025 | 11 July 2018 | Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use |
| MDA-2018-024R | 12 July 2018 | All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine. |
| MDA-2018-024 | 11 July 2018 | All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine. |
| MDA-2018-023 | 05 July 2018 | Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser. |
| MDA-2018-022R | 06 July 2018 | SAM XT Extremity Tourniquet – Recall due to the risk of tourniquet failing in use |
| MDA-2018-022 | 05 July 2018 | Recall due to the risk of tourniquet failing in use |
| MDA-2018-021 | 21 June 2018 | Alaris Smartsite Add-On Bag Access device – removal and destruction of specific batches due to risk of disconnection or leakage |
| MDA-2018-020 | 20 June 2018 | Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs – recall of specific lots due to risk of under delivery of medication |
| MDA-2018-019 | 11 June 2018 | JM103 and JM105 Jaundice Meters – risk of misinterpretation of measurement in hyperbilirubinemia cases |
| MDA-2018-018 | 31 May 2018 | Various Arrow Critical Care devices – recall due to incomplete packaging seals |
| MDA-2018-017 | 24 May 2018 | Cook Vacuum Pump for IVF – risk of electric shock or burn to operator |
| MDA-2018-016 | 18 May 2018 | Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results |
| MDA-2018-015 | 16 May 2018 | Gambro Ultrafilter U9000 microbial water filter for haemodialysis – risk of hypovolemia due to filter leaks during use |
| MDA-2018-014 | 02 May 2018 | Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated |
| MDA-2018-013 | 01 May 2018 | cobas b 221 instruments with AutoQC module – software limitation affecting automatic QC measurements |
| MDA-2018-012 | 26 April 2018 | BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology |
| MDA-2018-011 | 20 April 2018 | Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision |
| MDA-2018-010 | 28 March 2018 | All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment |
| MDA-2018-009 | 03 March 2018 | Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure |
| MDA-2018-008 | 22 February 2018 | Aquilon series of nebulisers – CE mark withdrawn and supply ceased |
| MDA-2018-007 | 15 February 2018 | Zimmer Biomet, specific hip and trauma instruments: risk of infection |
| MDA-2018-006 | 15 February 2018 | Plum 360 infusion pumps – user actions required to prevent risk of interrupted infusion or delay to treatment |
| MDA-2018-005 | 15 February 2018 | Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents. |
| MDA-2018-004 | 14 February 2018 | Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors |
| MDA-2018-003 | 22 January 2018 | In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products - precautionary measure |
| MDA-2018-002 | 15 January 2018 | All Philips HeartStart MRx monitors/defibrillators – significant delay in the supply of batteries |
| MDA-2018-001 | 12 January 2018 | Pacemakers & CRT-P - oversensing of minute ventilation sensor signal leading to risk of syncope & pre-syncope |