Medical device alerts archived in September 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
| Reference | Title |
| MDA/2005/067 | Guidant INSIGNIA and NEXUS implantable pacemakers |
| MDA/2005/070 | Guidant INSIGNIA and NEXUS implantable pacemakers |
| MDA/2005/072 | Medtronic Sigma®Implantable Pacemakers: specific model numbers |
| MDA/2006/055 | Handpieces used with oral / maxillofacial surgery drills |
| MDA/2009/014 | UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems. Manufactured by MECALL Srl |
| MDA/2009/023 | Zenith® Abdominal Aortic Aneurysm (AAA) Endovascular Grafts and associated H&L-B One-ShotTM Introduction Systems. Manufactured by Cook Medical Incorporated |
| MDA/2009/028 | Goldmann applanation tonometer prism. Manufactured by Haag-Streit Ag |
| MDA/2010/023 | Intracranial stent: SILK artery reconstruction device manufactured by Balt Extrusion and distributed in the UK by Pyramed Ltd |
| MDA/2010/050 | Implantable vagus nerve stimulators (VNS) |
| MDA/2010/094 | Umbilical cord clamp. All makes and models |
| MDA/2011/075 | Headrests attachment to operating tables with connection fixture: 1002.65A0 or 1002.65S0. Manufactured by Maquet Ltd |
| MDA/2012/072 | AlboGraft polyester vascular graft. Manufactured by LeMaitre. All lots |
| MDA/2012/079 | Defibrillators, Non Implantable External Defibrillator |
| MDA/2013/004 | Infusion pumps: Plum A+ single channel infuser systems |
| MDA/2013/020 | Acrobat Swing (AC Swing) arm. Manufactured by Ondal. Supplied by various companies to support operating lights and monitors. Delivered from 1999 to 2008 inclusive |
| MDA/2013/044 | Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and matrixORTHOGNATHlCS. Manufactured by Synthes GmbH. Specific lot numbers affected |
| MDA/2013/052 | HeartStart MRx Monitor/Defibrillator. Manufactured by Philips Healthcare. Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. Affected serial numbers from US00100100 to US00565942 inclusive |
| MDA/2014/014 | Samaritan® public access defibrillator Model: PAD 500P. Manufactured by HeartSine Technologies. Specific serial numbers affected |
| MDA/2014/040 | LIFEPAK® 1000 defibrillator. Manufactured by Physio-Control. All serial numbers. |
| MDA/2015/006 | Medical devices supplied by Atrium Medical a subsidiary of Maquet |
| MDA/2015/010 | PadPro and R2 multifunction electrodes - risk of delay to shock |
| MDA/2015/027 | Steel cannula infusion sets manufactured by Unomedical a/s |
| MDA/2015/029 | All Accu-Chek® Insight insulin pumps. Manufactured by Roche Diabetes Care |
| MDA/2016/018 | Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS – risk of failure to deliver a shock |
| MDA/2017/001 | Lung Ventilators |
| MDA/2017/002 | Reflection® dead blow mallet (all batches) – risk of exposure to lead particles |
| MDA/2017/004 | CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP – damaged lithium ion batteries may give off smoke, a bad smell or produce sparks |
| MDA/2017/007 | LMA® MAD Nasal™ intranasal mucosal atomization device – might not deliver a fully atomised plume of medication |
| MDA/2017/008 | LMA® mucosal atomization devices - topical anaesthesia may not be delivered in a fully atomised spray |
| MDA/2017/009 | BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy |
Published 2 September 2021