Reported Oct 29, 2014 · Terminated
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following…
Boston Scientific CRM Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific CRM Corp · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following
- models are not available in the US
models N106N107P106P107. Sterilized using ethylene oxide
- Product UsageBoston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide
- a variety of therapies including-Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy
- Lot codes and dates
- Model N106 - Serial numbers
222276222277222279222280222282222283222286222289222290222291222292222293222295222311222312222314222315222316222318222320222321222324222325222335222338222340222342222343222346222361222363222366222372222374222409
- Model N107 - Serial numbers
183 of 183 codes
100278100279100280100281100282100283100284100285100286100287100288100289100290100291100293100294100295100297100298100299100300100301100303100304100305100306100307100308100309100311100312100314100315100317100318100319100320100321100322100324100325100327100328100329100330100331100333100334100335100336100408100409100410100411100413100414100417100418100419100420
- Model N108 - Serial numbers
666667666668666669666670666671666672666673666675666676666677666678666679666680666681666682666683666684666685666686666687666688666689666690666691666693666694666695666696666697666699666700666702666703666704666705666706666707666708666710666711666713666714666715666716666717666718666719666720666721
- Model N118 - Serial numbers
1,846 of 1,846 codes
565136565138565140565146565149565151565152565154565155565157565158565160565163565164565165565167565168565170565173565176565177565178565179565181565182565186565187565188565189565190565191565192565193565194565197565198565199565200565202565204565209565210565319565320565321565326565328565329565330565331565332565334565335565336565337565338565339565342565343565344
- Model N119 - Serial numbers
1,939 of 1,939 codes
048289048292048294048295048296048297048298048299048300048302048303048304048306048307048308048309048310048311048312048313048314048315048318048319048323048325048326048330048332048336048337048338048341048344048408048410048412048413048414048415048416048418048419048420048422048423048425048426048428048430048434048436048440048442048444048447048534048535048537048538
- Model N106 - Serial numbers
- Amount recalled
- 31,144 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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