Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillators (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 cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure(HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798 USA.
Recall
- Recall Number
- Z-1556-2010
- Event Number
- 55216
- Firm
- Boston Scientific CRM Corp
- FEI Number
- 2124215
- Product Code
- LWP
- Status
- Terminated
- Root Cause
- PMA
- Initiated
- March 15, 2010
- Posted
- May 8, 2010
- Terminated
- April 5, 2012
- Address
- 4100 Hamline Ave N, Saint Paul, MN, 55112-5700
Description
Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillators (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 cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure(HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798 USA.
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.
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 models. To be complete and mitigate the possibility of retrieval errors, the ICD and CRT-D US models that may be on customer's shelves were included in the letter. The devices subject to retrieval, however, were those non-implanted devices with domestic customers. For questions, please contact the local representative (1-800-227-3422) for pick up and return or contact Boston Scientific Technical Services at 1.800.CARDIAC (227.3422).
nationwide within US only (OUS distribution not affected).
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