Reported Oct 22, 2025 · Ongoing
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott · 5050 Nathan Ln N · Plymouth, MN · 55442-3209
Is this the product you have?
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
- Lot codes and dates
- GTIN 05415067034618
- Batch Numbers
244 of 244 codes
100932131009358810095366100962691011867610131389101513331018096910286877103156611031764910329929103322971034417710350400103600301037417110375844104189541043176510433617104504621049209310494298105370001053774710538321105577101055787810558450105596551056970310570507105719021057190710574230105757461057575210577567105789531057972410580699105816121058168110583203105837931058703310587043105876531058906810589921105911781059123810592227106066281060672010608438106087081061146910611683
- Amount recalled
- 11810 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Stop using this product now
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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