Reported Oct 22, 2025 · Ongoing
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; 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, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
- Lot codes and dates
- GTIN 05415067034571
- Batch Numbers
1,804 of 1,804 codes
87074638728375884881488494288856153885977789307248948407908526791348789139151915170191545719170156917237892026841000587010014420100144221003583810060049100674951007448810093061100951191013324010143719101463361015024610150248101587501016325610168649101754791019167210206135102194591024628710250075102597211026699310268128102785491027894710278998102790231027996210282364102846131028613510299761103017201030172410302971103109651031319310321650103216841033021310334312
- Amount recalled
- 85803 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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