Reported Oct 22, 2025 · Ongoing
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; 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, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
- Lot codes and dates
- GTIN 05415067034557
- Batch Numbers
153 of 153 codes
8843948885503989063168913730892115489221468933195894732389493248958968895945289609868961409896325489654848965486899123689933659001917900304490030479012222901342890152939038354903923990659469066884907129491194879138236914773391484119156153915889110162247101733981020531010207502102180301022844910228450102304291023294010235434102354361024023510242138102429921024299510280672102880531028805710289553102896681028970910289759102978991033469510334845
- Amount recalled
- 3404 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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