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

Recall Z-1307-2025 — CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000

U.S. FDA — Device Enforcement · United States · 2025-02-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1307-2025
Date of alert
2025-02-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CardioFocus, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00859373007433
Reported risk: Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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