Abbott recalled 3,403 TactiFlex Sensor Enabled Ablation Catheters due to potential tip detachment during removal. The recall affects medical devices distributed worldwide. 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 recall involves the TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD. The affected batch numbers include 8843948, 8855039, 8906316, and others. This product was distributed worldwide.
Abbott identified a risk of tip detachment during the removal of the catheter from its packaging. This defect poses a high risk to patients as it could lead to complications during cardiac procedures.
There have been a limited number of reported incidents related to tip detachment. No injuries or deaths have been reported at this time.
Stop using the TactiFlex catheter immediately. Follow the recall instructions provided by Abbott and contact your healthcare provider for further guidance.
For more details, contact Abbott directly or visit their website. Additional information is available through the FDA's recall report.
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