Abbott recalls specific TactiFlex Sensor Enabled Ablation Catheters due to limited tip detachment events during removal from packaging. Affected units have unique batch numbers and GTIN.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott is recalling certain TactiFlex Sensor Enabled Ablation Catheters because a small number experienced tip detachment when removed from packaging. This could lead to potential injury during medical procedures if the catheter becomes detached unexpectedly.
The catheter tip can detach during removal from packaging, which may cause it to become loose or dislodged during medical procedures. This could potentially lead to injury if the detached tip causes unintended tissue damage or complications during the procedure.
Medical professionals using the recalled catheters for cardiac procedures are most at risk. Patients receiving these catheters during procedures may be affected if the device detaches unexpectedly.
Check for the model name 'TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F)' with the reference number A-TFSE-F. Affected units have specific batch numbers listed in the recall notice.
Review the product's batch number and GTIN to confirm if it matches the affected units listed in the recall notice.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Check for the model name 'TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F)' with reference number A-TFSE-F and specific batch numbers listed in the recall notice.
The recall does not specify a remedy, so contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0113-2026 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0113-2026 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
