Medtronic recalled its Abre Venous Self-Expanding Stent System on December 4, 2025, due to a potential Nitinol anomaly. This issue may lead to reduced stent diameter and corresponding radial force, increasing the risk of stent migration. The recall affects 442 units distributed worldwide, including the U.S.
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Inc or your healthcare provider for instructions. Notification method: Letter
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The recall involves the Abre Venous Self-Expanding Stent System with model numbers AB9G14120090, AB9G12100090, AB9G14080090, and others. The stents were distributed globally, including in the U.S. and several countries in Europe and Asia. The price range is not specified.
A Nitinol anomaly may cause the stent diameter to decrease when deployed, which reduces its radial force. This defect can lead to migration of the stent, posing a serious health risk.
No specific incidents or injuries related to this recall have been reported. The recall is classified as Class II due to the potential for serious health implications.
Patients and healthcare providers must stop using the affected stents immediately. Follow the manufacturer's recall instructions and contact Medtronic Inc or your healthcare provider for further guidance.
For more information, contact Medtronic at their official website or via customer support. Additional details are available on the FDA website.
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