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

Recall Z-1444-2021 — BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

U.S. FDA — Device Enforcement · United States · 2021-03-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1444-2021
Date of alert: 2021-03-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BIOTRONIK Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 60757356

Reported risk: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators 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-1444-2021 — BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

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