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

Recall Z-0282-2022 — Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Co

U.S. FDA — Device Enforcement · United States · 2021-10-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0282-2022
Date of alert: 2021-10-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category: device
Product type: Devices

Reported risk: The processing of collected episode data may fail due to a software error.

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.

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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