Abbott recalls 399 TactiFlex Sensor Enabled Ablation Catheters after reports of tip detachment during packaging removal. The recall covers devices worldwide. Stop using the device immediately and follow manufacturer 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 sensors enable precise mapping during ablation procedures. Clinicians rely on these devices for cardiac interventions.
Detachment of a catheter tip could complicate procedures and require additional intervention to recover the detached tip.
This recall is not part of a broader industry pattern to date.
Immediate clinical action required; impact primarily on healthcare providers and patients undergoing ablation.
Recall notification letters from Abbott; the FDA recall page linked in the notice; device packaging and labeling.
Refunds/replacements follow Abbott recall processes, typically weeks to months.
Maintain copy of recall notice, healthcare facility communication, and replacement records.
Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, UniD Curve D. REF A-TFSE-D. Category: Cardiac catheter. Quantity: 399 units. Distribution: Worldwide.
High hazard level with limited number of tip detachment events reported. No injuries or specific incident count provided in the supplied data.
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