Medtronic Inc. is recalling 442 Abre Venous Self-Expanding Stent Systems because the stents may have a manufacturing anomaly in the Nitinol material. This defect can cause the stent to have a smaller diameter than intended once it is deployed inside a patient's body, which reduces the outward force holding the stent in place. The recall involves 11 specific model numbers of the Abre Venous system used to treat venous disease.
The reduced stent diameter and outward force can cause the device to move or migrate from its original position. A migrating stent may fail to properly support the vein or could move into other areas of the circulatory system, potentially causing vascular damage or blockages.
Recall Z-1098-2026. Firm identifies Nitinol anomaly as root cause.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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