Abbott recalled 11,805 TactiFlex Sensor Enabled Ablation Catheters on September 10, 2025. The recall follows reports of tip detachment during catheter removal from packaging. Patients and healthcare providers must stop using the device immediately.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott or your healthcare provider for instructions. Notification method: Letter
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The TactiFlex Sensor Enabled Ablation Catheter is an 8F, 115 cm device, with model reference A-TFSE-FJ. It has been distributed worldwide.
The recall stems from a limited number of tip detachment events that occur during catheter removal from the packaging. This poses a high hazard level as it may compromise the device's effectiveness and safety.
There are no specific incidents of injury reported yet. However, the potential for harm exists due to the nature of the device and the reported detachment.
Patients and healthcare providers should stop using the TactiFlex catheters immediately. Follow the recall instructions provided by Abbott and contact your healthcare provider for further guidance.
For more details, contact Abbott directly. Visit the FDA recall page or check Abbott’s official website for further instructions.
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