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

Recall Z-0110-2026 — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

U.S. FDA — Device Enforcement · United States · 2025-09-10 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0110-2026
Date of alert
2025-09-10
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Abbott
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05415067034557
Reported risk: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
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.

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