HIGH

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

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

Quick Facts at a Glance

Recall Date
September 10, 2025
Hazard Level
HIGH
Brand
Abbott

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott or your healthcare provider for instructions. Notification method: Letter

Full Description

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter. Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.. Classification: Class I. Quantity: 11805 units. Distribution: Worldwide

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Brand
Abbott
Model Numbers
GTIN 05415067034618
Batch Numbers: 10093213
10093588
10095366
10096269
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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