Medical device alerts archived in December 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
| Reference | Title |
|---|---|
| MDA/2003/008 | External Pacemakers: Models - E4162, E4164, E4165 and E4166 (manufactured by APC Medical Ltd) |
| MDA/2007/023 | Boston Scientific Ltd: Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families |
| MDA/2009/038 | Implantable Pacemakers: Medtronic Kappa® 600/700/900 Series IPGs; Medtronic Sigma® 100/200/300 Series IPGs. |
| MDA/2010/012 | Teligen implantable cardioverter defibrillators (ICDs) and Cognis cardiac resynchronisation therapy defibrillators (CRT-Ds) – specific models. Manufactured by Boston Scientific. |
| MDA/2011/056 | Pacemaker. Reply and Esprit models that have been interrogated with programmer containing software version 2.24. Manufactured by Sorin CRM. |
| MDA/2011/060 | Dual Chamber Pacemakers. Medtronic models: Kappa 600, 700, 800 and 900; EnPulse; Adapta; Versa; Sensia; Relia. Vitatron models: E50A1, E60A1 and G70A1 |
| MDA/2011/067 | Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010. Manufactured by Cameron Health. |
| MDA/2011/073 | Implantable cardioverter defibrillator (ICD). Paradym, model numbers: VR 8250, DR 8550, CRT-D 8750 and 8770, VR 9250, DR 9550, CRT-D 9750 and 9770. |
| MDA/2011/079 | Implantable Pulse Generators (IPGs) – Neurostimulators. Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788). Manufactured by St Jude Medical. |
| MDA/2011/097 | Implantable pacemakers manufactured by Medtronic. EnRhythm®: Model P1501DR, EnRhythm MRI™ SureScan: Model EMDR01 IPG |
| MDA/2012/014 | Implantable cardioverter defibrillators (ICD). EnTrust VR/DR/AT. Models: D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, and D154VRC. Manufactured by Medtronic. |
| MDA/2012/070 | External pacemaker used with temporary endocardial pacing leads or epicardial pacing wires MICRO-PACE 4580. Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. |
| MDA/2013/001 | External pacemaker: MICRO-PACE REF 4580. Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. |
| MDA/2013/036 | External pacemaker: MICRO-PACE REF 4580.Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. |
| MDA/2017/012 | V60 ventilator – potential for unexpected shutdown |
| MDA/2019/022 | 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/2019/035 | 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 |
Published 3 December 2021