Recall Z-1098-2026— Medtronic Inc

Name: FDA recall Z-1098-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-04

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc, initiated 2025-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090. Reason: 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..

Recalling firm: Medtronic Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-04
Firm location: Plymouth, MN, United States

Product description

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.