Recall Z-1558-2010 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Boston Scientific CRM Corp
CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac Resynchronization Therapy Defibrillator (CRT-D). These CRT-Ds provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardia
| Date | May 8, 2010 (initiated Mar 15, 2010) |
| Status | Terminated |
| Reason | Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the US Food & Drug Administration. |
| Root cause | PMA |
| Action | BSC issues press release dated 15 March 2010. FDA press release posted 18 March 2010. On 15 March 2010, BSC Sales Representatives begin removal of devices from health care facilities stock. Starting 22 March 2010 BSC sent a physician letter dated 22 March 2010 to implanting and following physicians via FedEx. The Urgent Medical Device Recall letter described the issue of why devices were being removed from hospital shelves. The letter did NOT recommend any changes to normal follow-up procedures for patients implanted with an ICD or CRT-D device. The letter included ALL potential US model |
| Quantity | 6 |
| Distribution | nationwide within US only (OUS distribution not affected). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.