TactiFlex Sensor Enabled Ablation Catheter recall
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Why was TactiFlex Sensor Enabled Ablation Catheter recalled?
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 05415067034670, Batch Numbers: 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567, 10371569, 10371577, 10399929, 10418884, 10418885, 10418895, 10429561, 10429563, 10479188, 10479190, 10482343, 10482351, 10482363, 10482378, 10513080, 10533833, 10533851, 10533854, 10566078, 10597230, 10646250, 10646251, 10646253, 10673213, 10673240, 10684728, 10684732, 10684739, 10684740, 10688513, 10692386, 10695444, 10705803, 10710366, 10713073, 10758992, 10792240, 10792924, 10803221, 10803222, 10812417, 10812431, 10830792, 10830798, 10835329, 10835331, 10861887, 10866457, 10868070, 10870874, 10872753, 10878395, 10878673, 10879391, 10879406, 10978688, 10978690.
- Product
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- Recalling firm
- Abbott
- Quantity
- 1960 units
- Distribution
- Worldwide
- Recall date
- October 22, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)