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U.S. Department of Health and Human Services

Class 2 Device Recall VENTAK PRIZM Implantable Cardioverter Defibrillator

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 Class 2 Recall
VENTAK PRIZM Implantable Cardioverter Defibrillator
see related information
Date Posted May 08, 2010
Recall Status1 Terminated on April 05, 2012
Recall Number Z-1559-2010
Recall Event ID 55216
Premarket Approval
PMA Number
P960040/S012
Product Classification Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
Product VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR HE, model 1853 and 1858, PRIZM VR HE, model 1857, PRIZM 2 VR model 1860 and PRIZM 2 DR model 1861. The 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. Bradycardia pacing, including adaptive-rate features is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA
Code Information The device serial numbers are only provided for devices subject to the retrieval. For model number with no serial numbers there were no non-implanted devices with domestic customers. Once the required BSC submissions and FDA reviews are completed, the BSCs distribution and implant restrictions will no longer apply. Model 1850, 1852, 1855 and 1856, no serial numbers will be retrieved. Model 1851, serial number: 301173 Model 1853, serial number: 405161 Model 1857, serial numbers: 701901, 705521, 705555, 705564, 705568, 705575, 705624, 705721, 705759, 705774. Model 1858, serial numbers: 801463, 801487, 801489, 801505, 801511, 801512, 801517, Model 1860, serial number 131043 Model 1861, serial numbers 201166, 230949
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 22
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 = CARDIAC PACEMAKERS, INC.
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