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

Recall Z-0879-2021 — EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

U.S. FDA — Device Enforcement · United States · 2020-11-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0879-2021
Date of alert
2020-11-13
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: There is potential for fractures which results in the inability to delivery therapy.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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