The Recall Desk

FDA (Devices) recall action 69291

Boston Scientific CRM Corp recalled 2 products on 2014-10-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-10-29
Critical
0
Units
62,288

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-10-29

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-Ds and TELIGENT ICDs due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2014-10-29

    Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion

    Boston Scientific is recalling TELIGEN ICDs and COGNIS CRT-Ds due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillator
    Category
    Distribution
    4 states