268 alerts

For

Medical device alert

  1. Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)

    Manufactured by Synthes GmbH – cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.

  2. Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)

    Manufactured by Abbott – cases of valvular insufficiency and early revision.

  3. Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)

    Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.

  4. Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)

    Manufactured by Philips Respironics – sudden loss of power due to component failure, which may not always be accompanied by an alarm or visual warning.

  5. Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)

    The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

  6. Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)

    This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)

  7. Pilling Clear Advantage aortic punch – risk of infection due to packaging failure (MDA/2020/014)

    Manufactured by Teleflex – if the packaging is not intact, the device won’t be sterile.

  8. COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)

    All manufacturers – there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.

  9. Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)

    All anaesthesia machines with ventilators - using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability.

  10. Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)

    Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market during a review by MHRA.

  11. Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)

    Manufactured by NuVasive Inc. – risk of end cap separation after implantation.

  12. Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models

    Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.

  13. Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)

    Manufactured by Olympus Medical Systems Corp – instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.

  14. All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDA/2020/007)

    Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion.

  15. Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents (MDA/2020/006)

    Manufactured by Cordis – instructions for use contain incorrect MRI compatibility information.

  16. t:slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters (MDA/2020/005)

    Manufactured by Tandem Diabetes Care – an exposed component may cause an electrical shock to the user or patient

  17. Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection (MDA/2020/004)

    Manufactured by Mavidon – products may be contaminated with the microorganism Burkholderia cepacia leading to an infection risk to patients.

  18. Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy (MDA/2020/003)

    Manufactured by Philips – due to hardware or software issues (described in two separate FSNs) the device may fail to start, unexpectedly restart or deliver defibrillation therapy at the wrong energy level.

  19. Convex two-piece skin barriers (Natura /Surfit/Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002)

    Manufactured by ConvaTec – specific batches of convex two-piece skin barriers have been incorrectly manufactured with off-centre starter/stoma hole.

  20. NIPPY ventilator range (all models) – update to instructions for use (MDA/2020/001

    Manufactured by Breas Medical Limited – maintenance schedule now includes changing the internal memory/alarm battery every 3 years.

  21. Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury

    Manufactured by Teleflex Medical (Arrow) – do not use needles if the safety cap is not in place as the risk of needle stick injury is increased and sterility of the needle may be compromised if packaging is punctured.

  22. ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring (MDA/2019/045)

    Manufactured by GE – central monitoring station or bedside monitor may not provide visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring when used with affected telemetry system.

  23. BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking (MDA/2019/044)

    Manufactured by Flexicare Medical – loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.

  24. Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 (MDA/2019/043)

    Manufactured by Medicina – syringes incorrectly packaged with a needle could mean they are not sterile and could cause a needlestick injury.

  25. Natus gold cup electrodes and snap electrode leads – risk of electric shock

    Manufactured by Natus - GN Otometrics A/S: an exposed conductor may cause an electric shock to the user or patient.

  26. Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041)

    Manufactured by Terumo BCT – inadequately broken anticoagulant ‘frangible’ may lead to clotting and inadequate therapy during apheresis procedures.

  27. Alaris™ Gateway Workstation and Alaris™ Gateway Workstation web browser user interface (MDA/2019/040)

    Manufactured by Becton Dickinson – if a software security vulnerability is exploited, an attacker with malicious intention could remotely install unauthorised firmware.

  28. Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039)

    Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.

  29. 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/2019/038)

    Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102).

  30. Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037)

    Manufactured by Baxter – Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown.

  31. Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use (MDA/2019/036)

    Manufactured by Teleflex Medical – disconnection can result in inadequate oxygenation and ventilation requiring medical intervention to avoid hypoxia, severe neurological injury or death.

  32. 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/2019/035)

    Manufactured by Rocket Medical and NuSurgix – potential incompatibility between ethyl chloride spray and the device.

  33. Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) (MDA/2019/034)

    Manufactured by Ecolab/Microtek Medical Malta Ltd – bacterial contamination may cause an infection in patients.

  34. Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit (MDA/2019/033)

    Manufactured by Intersurgical – leaks or disconnection can result in insufficient oxygenation requiring medical intervention to avoid severe injury.

  35. Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use (MDA/2019/032)

    Manufactured by Intersurgical, used in devices made by other companies: cracks in swivel elbow connectors may lead to prescribed ventilation not being delivered.

  36. Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) (MDA2019/031)

    Manufactured by Clinical Innovations – if the device fails to generate or maintain a vacuum during the assisted delivery of a baby, additional intervention will be needed.

  37. All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030)

    Manufactured by CME (a BD company) – function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices.

  38. Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion

    Manufactured by Smiths Medical: due to a manufacturing process failure, needles may be occluded, potentially causing a delay to treatment.

  39. Microneedling pens: Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection (MDA/2019/028)

    Manufactured by Equipmed and other trading names (listed in the ‘Manufacturer contacts’ section), distributed in the UK by Naturastudios.

  40. Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate (MDA/2019/027)

    Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

  41. Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes

    Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.

  42. IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low (MDA/2019/025)

    Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.

  43. Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024)

    Manufactured by B.

  44. 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/2019/023R)

    Recommendations following publicised concerns over an increase in patient mortality from two years after treatment.

  45. Aisys and Aisys CS2 anaesthesia devices with Et Control option and software versions 11, 11SP01 and 11SP02 – risk of patient awareness due to inadequate anaesthesia (MDA/2019/022)

    Manufactured by GE Healthcare – device may fail to deliver the set agent concentration in End Tidal Control mode.

  46. Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance (MDA/2019/021)

    Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. Update includes fu…

  47. Hoists: Molift Mover 180/205 mobile hoist and Molift Air ceiling hoist - all sizes of 2-point sling bars – risk of fracture of hooks in use (MDA/2019/020)

    Manufactured by Etac and supplied in UK by R82 UK Ltd – if the hooks connecting the spreader bar to the hoist break during use, the patient could fall.

  48. Ethicon Curved Intraluminal Staplers – risk of failure of staple lines (MDA/2019/019)

    Manufactured by Ethicon – use of affected devices may result in failure of staple line which could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding.

  49. Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment (MDA/2019/018)

    Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.

  50. 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/2019/017)

    Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.