Abbott recalled 1,958 TactiFlex Sensor Enabled Ablation Catheters worldwide. A limited number of tip detachment events occurred during catheter removal from packaging. Patients and healthcare providers should stop using the device immediately and follow Abbott's 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 TactiFlex ablation catheter is used in cardiac electrophysiology procedures to treat arrhythmias by delivering energy to targeted tissue.
If the catheter tip detaches during removal from packaging, it could cause injury or complicate the procedure.
This recall is not described as part of a broader industry pattern in the supplied information.
Hospitals must screen inventory, halt use of affected devices, and coordinate with Abbott for replacement or refunds. The recall may affect procedural scheduling and supply chains.
Recall details appear on the FDA enforcement page and the Abbott recall communications; packaging and labeling will show model identifiers and batch codes.
Recall processing and replacement or refunds may take several weeks; hospitals should plan accordingly.
Keep copies of the recall notice, take photos of labels and batch codes, and log communications with Abbott and hospital procurement
Brand: Abbott Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, UniD Curve F Reference: REF A-TFSE-F Classification: Class I recall Quantity: 1,958 units Distribution: Worldwide Identifiers: GTIN 05415067034670; Batch Numbers 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567 Recall date: 2025-09-10 Status: ACTIVE Hazard: Tip detachment during catheter removal from packaging Hazard level: HIGH Recall URL: https://www.accessdata.fda.gov/scripts
No injuries or incidents have been reported.
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