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

Recall Z-2073-2019 — ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

U.S. FDA — Device Enforcement · United States · 2019-06-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2073-2019
Date of alert
2019-06-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
St Jude Medical Inc.
Product category
device
Product type
Devices
Reported risk: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
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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