Abbott: Device Recall

Recall #Z-0109-2026 · 09/10/2025

Class I: Dangerous

Recall Details

Recall Number: Z-0109-2026
Classification: Class I
Product Type: Device
Recalling Firm: Abbott
Status: Ongoing
Date Initiated: 09/10/2025
Location: Plymouth, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 407 units

Reason for Recall

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Product Description

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

Distribution Pattern

Worldwide

Other Recalls by Abbott

Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class II: Risk 03/17/2025

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

View all recalls by Abbott →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.