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U.S. Department of Health and Human Services

Class 2 Device Recall CONFIENT Implantable Cardioverter Defibrillator

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 Class 2 Recall
CONFIENT Implantable Cardioverter Defibrillator
see related information
Date Posted May 08, 2010
Recall Status1 Terminated on April 05, 2012
Recall Number Z-1555-2010
Recall Event ID 55216
Premarket Approval
PMA Number
P960040
Product Classification Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Manufacturer 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.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
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 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).
Quantity in Commerce 55
Distribution nationwide within US only (OUS distribution not affected).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWP and Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = LWP and Applicant = BOSTON SCIENTIFIC CLONMEL LIMITED
PMAs with Product Code = LWP and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = LWP and Applicant = BOSTON SCIENTIFIC CORPORATION
PMAs with Product Code = LWP and Applicant = BOSTON SCIENTIFIC CORPORATION (BSC)
PMAs with Product Code = LWP and Applicant = BOSTON SCIENTIFIC CRV
PMAs with Product Code = LWP and Applicant = BOSTON SCIENTIFIC-CRM
PMAs with Product Code = LWP and Applicant = CARDIAC PACEMAKERS, INC.
PMAs with Product Code = LWP and Applicant = GUIDANT CORP.
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