Recall Z-0111-2026— Abbott
Class I · Ongoing
Class I FDA medical device recall by Abbott, initiated 2025-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter. Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging..
- Recalling firm
- Abbott
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-09-10
- Firm location
- Plymouth, MN, United States
Product description
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Reason for recall
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.