Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0088-2015 — 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 defibrillators (ICDs) provide a v

U.S. FDA — Device Enforcement · United States · 2014-09-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0088-2015
Date of alert: 2014-09-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific CRM Corp
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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