Abbott recalled 1,958 TactiFlex Sensor Enabled Ablation Catheters on September 10, 2025. The recall follows reports of tip detachment during 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
The recalled product is the TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F. The affected batch numbers include 8894357 and 8917490, among others. These products distributed worldwide were sold at multiple retailers.
Abbott identified a risk of tip detachment when removing the catheter from its packaging. This detachment poses a high hazard level, which can lead to complications during medical procedures.
There have been a limited number of reported incidents involving tip detachment. No specific numbers of injuries or deaths related to these incidents have been disclosed.
Stop using the TactiFlex Ablation Catheter immediately. Follow the recall instructions provided by Abbott. For further information, contact Abbott or your healthcare provider.
For details, visit Abbott's website or call their customer service. More information is available at the FDA recall report link.
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