Reported Oct 23, 2013 · Terminated
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available…
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 TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following
- models are not available in the USmodels F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support
- Lot codes and dates
- Model E102
- Serial Numbers
4,072 of 4,072 codes
000138000139000140000142000145000146000147000151000152000153000154000161000162000163000166000167000169000170000172000173000174000175000176000177000178000182000183000184000185000187000188000191000192000193000194000196000199000200000202000203000204000207000209000210000213000214000215000216000218000219000220000221000222000224000226000227000228000229000230000232
- Amount recalled
- 38,500 total worldwide
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
Why it was recalled
The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
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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