Saturday, July 13, 2024

Catheter Kits Recalled by Teleflex/Arrow International Due to Serious Safety Risks

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Teleflex, along with its subsidiary Arrow International, has initiated a Class I recall—the most serious type of recall—of its Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits. This recall follows the discovery of a manufacturing defect that may prevent the balloon from fully inflating, potentially causing severe injury or death.

The recalled products include the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, with the following product codes: IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB-05850-LWS, IAB-06830-U, IAB-06840-U, and IAB-06850-U. A total of 16,959 units distributed between May 7, 2022, and April 8, 2024, are affected. The recall was initiated on April 29, 2024.

Recall of Catheter Kits Due to Manufacturing Defect Poses Serious Health Risks

These catheter kits are used in conjunction with a balloon pump to provide circulatory support during cardiac and non-cardiac surgeries and in treating acute coronary syndrome or heart failure complications in adults. The recall was initiated after identifying a manufacturing error that may have caused the catheter’s balloon to become over-twisted. This defect can prevent full balloon inflation, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage or insertion difficulties.

Use of these defective devices may result in serious injury, including blood loss, arterial tearing, unstable blood pressure, myocardial ischemia, or death. To date, Teleflex/Arrow International has received 322 complaints, with 31 reported injuries and 3 deaths potentially linked to this issue.

Catheter Kits

Urgent Action Required for Healthcare Providers and Distributors Amid Teleflex Catheter Kits Recall

Patients receiving circulatory support using the affected IAB Catheter Kits and healthcare professionals utilizing these kits in their practice are advised to take immediate action. Healthcare professionals should ensure a backup IAB catheter is available, inspect catheters for over-twisted balloon wrap or bent shaft, use fluoroscopic guidance for insertion and assess balloon inflation, and respond promptly to pump alarms indicating helium leakage or catheter restriction. Faulty catheters should be replaced immediately, and incidents should be reported to Teleflex.

Medical facilities are instructed to check their inventory for affected products, and complete and return the acknowledgment form to Teleflex. Distributors must notify customers of the recall, ensure they return the acknowledgment form, include recall notifications with future distributions of affected products, and confirm completion of field activities with Teleflex.

This recall underscores the critical importance of stringent quality control measures in medical device manufacturing. The proactive steps taken by Teleflex/Arrow International aim to mitigate the risks associated with this defect and safeguard patient health. For more information and to report issues, healthcare providers and distributors should contact Teleflex using the provided recall communication channels.

 

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Resource: Food and Drug Administration, June 13, 2024

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