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 Abre Venous Self-Expanding Stent System is a medical device used to treat venous obstructions. Patients typically receive this stent to improve blood flow in affected veins.
The Nitinol anomaly can cause the stent to reduce in diameter when deployed, which compromises its effectiveness and can lead to migration from the intended location.
This recall is not part of a broader industry pattern.
Patients using this stent face potential risks that may require medical intervention, making this recall critical for ensuring patient safety.
Model numbers and lot numbers can typically be found on the device packaging or accompanying documentation.
Expect a response from the manufacturer within 4-6 weeks regarding the recall process and refunds.
Keep all receipts, correspondence with the manufacturer, and any medical records related to the stent.
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.
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