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 these devices have experienced tip detachment during removal from packaging. This could potentially cause injury if the catheter becomes dislodged during medical procedures.
The catheter tip can detach during removal from its packaging, which might cause injury if the detached tip becomes dislodged during medical procedures. This is a limited issue affecting only specific batch numbers of the product.
Healthcare professionals using the TactiFlex Sensor Enabled Ablation Catheter for cardiac procedures are most likely affected. Patients using these catheters during procedures are at risk if the device detaches.
Check for the product name 'TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ'. Affected units have specific batch numbers listed in the recall notice.
Identify the product by checking the batch numbers listed in the recall notice (e.g., 10093213, 10093588, etc.) or the GTIN 05415067034618.
The recall indicates a limited number of tip detachment events during removal from packaging, but the risk is low and only affects specific batches. Patients using the catheter during procedures are at risk if the tip detaches.
Check the batch numbers listed in the recall notice (e.g., 10093213, 10093588, etc.) or the GTIN 05415067034618 on the packaging.
The recall does not specify a remedy, so contact Abbott directly for guidance on handling the product.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0112-2026 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0112-2026 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.
