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

Recall Z-1069-2019 — Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (

U.S. FDA — Device Enforcement · United States · 2019-03-04 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1069-2019
Date of alert: 2019-03-04
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00643169522572

Reported risk: The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

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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