Abbott recalled 11,805 TactiFlex Sensor Enabled Ablation Catheters worldwide. The devices may detach the tip during removal from packaging. Healthcare providers and patients should stop using the device immediately and follow Abbott's recall instructions. Check with Abbott or your healthcare provider for 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 Sensor Enabled Ablation Catheter is used in electrophysiology for cardiac tissue ablation. It is designed for catheter-based procedures.
A limited number of tip detachment events have occurred during removal from packaging. A detached tip could pose a physical hazard during handling or subsequent use.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics using the affected devices may need to identify and replace lot-specific catheters. The recall could affect procedural scheduling and inventory management.
Look on the device packaging and labeling; recall notices from Abbott and FDA listing.
Refunds or replacements typically take 4-8 weeks.
Keep the recall notice, packaging, serial/batch numbers, photos, and correspondence with Abbott or distributors for records.
Model numbers: A-TFSE-FJ GTIN: 05415067034618 Batch Numbers: 10093213, 10093588, 10095366, 10096269, 10118676, 10131389, 10151333, 10180969, 10286877, 10315661, 10317649, 10329929, 10332297, 10344177, 10350400, 10360030, 10374171, 10375844, 10418954 Length: 115 cm Size: 8F Curve: BiD Curve F-J Sold worldwide Sold since: Unknown Price: Unknown
Abbott reports a limited number of tip detachment events during packaging removal. No injuries or adverse patient events have been reported to date.
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