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

Recall Z-1485-2022 — Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4

U.S. FDA — Device Enforcement · United States · 2022-06-22 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1485-2022
Date of alert: 2022-06-22
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): 00763000178451

Reported risk: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (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.

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.

Recall Z-1485-2022 — Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4

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