Abbott recalls TactiFlex Sensor Enabled Ablation Catheters due to limited tip detachment events during removal from packaging. Affected units have specific 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 after becoming aware of tip detachment events during removal from packaging. This could lead to injury if the catheter detaches unexpectedly during use.
The catheter tip may detach during removal from packaging, potentially causing injury if it becomes dislodged during medical procedures. This is a limited issue observed in specific batch numbers.
Cardiologists and medical professionals who use the recalled catheters for heart procedures. Patients undergoing these procedures are at risk if the catheter detaches during removal.
Check for the model name 'TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D'. Look for batch numbers listed in the recall record or the GTIN 05415067034656.
Identify the model and batch numbers listed in the recall record to confirm if your catheter is affected.
The recall indicates a limited number of tip detachment events during removal from packaging, but the risk is low and only affects specific batch numbers.
Check for the model name 'TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D' and batch numbers listed in the recall record.
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-0109-2026 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0109-2026 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.
