Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
TactiFlex Sensor Enabled Ablation Catheter Recalled by Abbott Due to Abbott has become aware of a limited number...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott directly.
Affected Products
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Quantity: 11810 units
Why Was This Recalled?
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Where Was This Sold?
Worldwide
About Abbott
Abbott has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report