TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Reported: October 22, 2025 Initiated: September 10, 2025 #Z-0112-2026
Product Description
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Reason for Recall
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Details
- Recalling Firm
- Abbott
- Units Affected
- 11810 units
- Distribution
- Worldwide
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter. Recalled by Abbott. Units affected: 11810 units.
Why was this product recalled? ▼
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Critical. Recall number: Z-0112-2026.
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