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

Recall Z-2543-2019 — Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

U.S. FDA — Device Enforcement · United States · 2019-08-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2543-2019
Date of alert
2019-08-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
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.

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