Abbott recalled 399 TactiFlex Sensor Enabled Ablation Catheters on September 10, 2025. The recall stems from a limited number of incidents where catheter tips detached during removal from packaging. Patients and healthcare providers must stop using the device immediately and follow recall instructions.
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 recalled product is the TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D. The recall involves 399 units distributed worldwide.
Abbott reported tip detachment events during the removal of the catheter from its packaging. This poses a risk of injury to patients during medical procedures.
There have been a limited number of reported incidents involving tip detachment. Specific injury numbers are not disclosed.
Stop using the catheter immediately. Follow the recall instructions provided by Abbott. Contact Abbott or your healthcare provider for further instructions.
For further information, consumers can visit Abbott's website or call their customer service line. Additional recall details are available on the FDA website.
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