Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation(VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798. USA.
This recall has been terminated (originally issued May 8, 2010).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- March 15, 2010
- Posted
- May 8, 2010
- Terminated
- April 5, 2012
- Recall Number
- Z-1555-2010
- Quantity
- 55
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
nationwide within US only (OUS distribution not affected).
Lot / Code Info
Model E030, serial numbers: 504800, 505054, 505073, 506067, 506886, 506961, 507219, 507236, 507255, 507268, 507292, 507304, 507332, 507372, 507381, 507388, 507412, 507424, 507446, 507448, 507449, 507454, 507467, 507527, 507538, 507577, 507594, 507600, 507607, 507614, 507618, 507625, 507728, 507742, 507757, 507785, 507829, 507840, 507882, 507898, 507903, 507904, 507923, 507940, 507943, 507944, 507952, 507960, 507963, 507966, 507984, 508001, 508008, 508059, 508130.
Root Cause
PMA
Action Taken
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).