Abbott recalled 3,403 TactiFlex Sensor Enabled Ablation Catheters sold worldwide. The devices may detach a tip during removal from packaging. Hospitals and providers should stop using the devices and follow the manufacturer’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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TactiFlex Sensor Enabled Ablation Catheters are used in electrophysiology to perform cardiac ablation procedures. The 8F, 115 cm length with Bi-D curve is designed for navigating the heart during therapy.
A detached tip during removal from packaging could remain in the device or be introduced into a patient, creating a risk during a procedure.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics must review inventory and quarantine affected lots. The recall could cause procedural delays and procurement disruption while replacements are arranged.
Recall notices and guidance may be found via Abbott and the FDA recall page linked in the notice.
Refunds or replacements are typically processed within weeks to months, depending on Abbott procedures and hospital inventory needs.
Keep the recall notice, device labels showing REF, GTIN, and batch numbers, photos of packaging, and all correspondence related to the recall.
Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, BiD Curve D-D. REF: A-TFSE-DD. GTIN: 05415067034557. Batch numbers include: 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8958968, 8959452, 8960986, 8961409, 8963254, 8965484, 8965486, 8991236, 8993365, 9001917. Sold worldwide. Price not disclosed.
No injuries or incidents have been reported.
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