510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-1554-2010

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119...

Boston Scientific Corporation / initiated 2010-03-15 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Boston Scientific CRM Corp began a recall of Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1554-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.
Product code
LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
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.
Root cause tag
manufacturing process
FDA 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 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
799
Distribution
nationwide within US only (OUS distribution not affected).
Product codes and lots
Model N118, serial numbers: 564225, 568144, 569074, 569104, 569150, 569690, 569737, 569866, 569996, 569998, 570003, 578083, 578441, 578668, 578673, 578746, 578748, 578758, 578761, 578800, 578810, 578822, 578834, 578845, 578855, 578893, 578918, 578921, 578924, 578944, 578945, 578953, 578956, 578975, 578978, 578984, 579024, 579031, 579043, 579055, 579070, 579085, 579100, 579105, 579123, 579200, 579228, 579448, 579502, 579519, 579587, 579595, 579605, 579624, 579707, 579773, 579776, 579780, 579789, 579793, 579794, 579795, 579798, 579800, 579803, 579809, 579810, 579811, 579813, 579817, 579818, 579819, 579844, 579857, 579862, 579866, 579868, 579879, 579880, 579894, 579897, 579900, 579906, 579914, 579916, 579920, 579927, 580007, 580315, 580337, 580379, 580391, 581909, 581922, 581960, 581966, 581974, 581999, 582012, 582025, 582028, 582052, 582068, 582069, 582094, 582099, 582101, 582105, 582131, 582137, 582152, 582159, 582200, 582225, 582278, 582279, 582280, 582313, 582317, 582329, 582330, 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