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

Recall Z-1811-2023 — ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators

U.S. FDA — Device Enforcement · United States · 2023-05-10 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1811-2023
Date of alert
2023-05-10
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00643169720565
Reported risk: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
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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