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