Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model E102, Serial Numbers: 000138, 000139, 000140, 000142, 000145, 000146, 000147, 000151, 000152, 000153, 000154, 000161, 000162, 000163, 000166, 000167, 000169, 000170, 000172, 000173, 000174, 000175, 000176, 000177, 000178, 000182, 000183, 000184, 000185, 000187, 000188, 000191, 000192, 000193, 000194, 000196, 000199, 000200, 000202, 000203, 000204, 000207, 000209, 000210, 000213, 000214, 000215, 000216, 000218, 000219, 000220, 000221, 000222, 000224, 000226, 000227, 000228, 000229, 000230, 000232, 000234, 000235, 000236, 000240, 000241, 000244, 000247, 000248, 000249, 000251, 000252, 000254, 000256, 000258, 000260, 000262, 000263, 000265, 000266, 000268, 000269, 000270, 000271, 000272, 000273, 000274, 000275, 000276, 000277, 000278, 000282, 000284, 000287, 000288, 000289, 000290, 000292, 000294, 000295, 000297, 000299, 000300, 000302, 000304, 000306, 000307, 000309, 000310, 000311, 000314, 000316, 000321, 000322, 000323, 000324, 000325, 000330, 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
β οΈ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific CRM Corp
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models 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.
Product Codes/Lot Numbers:
Model E102, Serial Numbers: 000138, 000139, 000140, 000142, 000145, 000146, 000147, 000151, 000152, 000153, 000154, 000161, 000162, 000163, 000166, 000167, 000169, 000170, 000172, 000173, 000174, 000175, 000176, 000177, 000178, 000182, 000183, 000184, 000185, 000187, 000188, 000191, 000192, 000193, 000194, 000196, 000199, 000200, 000202, 000203, 000204, 000207, 000209, 000210, 000213, 000214, 000215, 000216, 000218, 000219, 000220, 000221, 000222, 000224, 000226, 000227, 000228, 000229, 000230, 000232, 000234, 000235, 000236, 000240, 000241, 000244, 000247, 000248, 000249, 000251, 000252, 000254, 000256, 000258, 000260, 000262, 000263, 000265, 000266, 000268, 000269, 000270, 000271, 000272, 000273, 000274, 000275, 000276, 000277, 000278, 000282, 000284, 000287, 000288, 000289, 000290, 000292, 000294, 000295, 000297, 000299, 000300, 000302, 000304, 000306, 000307, 000309, 000310, 000311, 000314, 000316, 000321, 000322, 000323, 000324, 000325, 000330, 000332, 000334, 000335, 000337, 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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0026-2014
Related Recalls
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
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
A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.