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

Recall Z-2147-2014 — Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) syste

U.S. FDA — Device Enforcement · United States · 2014-06-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2147-2014
Date of alert: 2014-06-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific CRM Corp
Product category: device
Product type: Devices

Reported risk: 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.

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

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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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