Medtronic Inc recalls Abre Venous Self-Expanding Stent System

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.

Beginning 04-Dec-2025, Medtronic distributed an Urgent Medical Device Recall notice to all U.S. consignees who have impacted products via mail courier. Consignees were instructed to complete and return a response form to the firm and to return any affected product they may have.

• FDA enforcement recordOfficial FDA database entry for Z-1098-2026
• FDA device classification · QANOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.