Reported Oct 22, 2025 · Ongoing
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; 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, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
- Lot codes and dates
- GTIN 05415067034656
- Batch Numbers
100 of 100 codes
88942318915981902964092550061000163110053399101036531012040810151069101943861019438810217380103896531042958410440518105132131051322510513232105132351055132610562041105620471056204910566077105972311059724210597249105972601061357210613581106135831061358510632079106326211063262610632634106462491067301110675350106768581067774910680007107572101078526610798695107986971081672310817847108178491085090610850907108581571085816010860077108717031088576110885921108899191089212610896652
- Amount recalled
- 407 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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