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 of them have experienced tip detachment during removal from packaging. This could potentially cause injury during medical procedures if the catheter becomes detached.
The catheter tip can detach during removal from its packaging, which could lead to injury if the detached tip causes damage during medical procedures. This is a rare occurrence but requires attention due to the potential for harm.
Medical professionals using the specific TactiFlex Sensor Enabled Ablation Catheters with the listed batch numbers and GTIN are most at risk. Patients undergoing procedures with these catheters may also be affected.
Check for the product name 'TactiFlex Sensor Enabled Ablation Catheter', 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD. Affected units have specific batch numbers and the GTIN 05415067034557.
Verify the product name, model, and batch numbers listed in the recall notice to confirm if your catheter is affected.
The recall reports limited tip detachment events during removal from packaging, but this is a rare occurrence that could potentially cause injury during medical procedures.
Check for the product name 'TactiFlex Sensor Enabled Ablation Catheter', 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD with the specific batch numbers listed in the recall notice.
The recall does not specify a remedy, so contact Abbott directly to determine if your catheter is affected and what steps to take.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0110-2026 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0110-2026 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.
