UniD curve F ablation catheters recalled after tip detachment from packaging
Abbott is recalling 1,960 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve F configuration after becoming aware of tip detachment events during removal from the packaging.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
TactiFlex Sensor Enabled Ablation Catheters, 8F, 115 cm, UniD Curve F, REF A-TFSE-F, are being recalled.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The recall covers 1,960 units carrying GTIN 05415067034670, across batch numbers including 8894357, 8917490, 8984945, 10061309, 10061314, 10061316 and 10061317. Distribution was worldwide. The FDA has classified the recall as Class I.
Electrophysiology labs should inspect the catheter before use and follow Abbott's instructions for affected batch numbers.
The recalled product
- Product
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- Manufacturer
- Abbott
- Hazard
- tip-detachment
- device-defect
- ablation-catheter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 05415067034670
- Batch Numbers: 8894357
- 8917490
- 8984945
- 10061309
- 10061314
- 10061316
- 10061317
- 10084510
- 10084518
- 10089968
- 10089971
- 10099711
- 10132013
- 10132015
- 10132017
- 10217367
- 10360478
- 10360488
- 10371567
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22