Reported Oct 22, 2025 · Ongoing
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; 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, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- Lot codes and dates
- GTIN 05415067034670
- Batch Numbers
76 of 76 codes
889435789174908984945100613091006131410061316100613171008451010084518100899681008997110099711101320131013201510132017102173671036047810360488103715671037156910371577103999291041888410418885104188951042956110429563104791881047919010482343104823511048236310482378105130801053383310533851105338541056607810597230106462501064625110646253106732131067324010684728106847321068473910684740106885131069238610695444107058031071036610713073107589921079224010792924108032211080322210812417
- Amount recalled
- 1960 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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