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

Recall Z-0928-2021 — Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

U.S. FDA — Device Enforcement · United States · 2020-11-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0928-2021
Date of alert: 2020-11-15
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: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

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-0928-2021 — Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

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