FDA-Device2024-03-27Class II

Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

Medtronic Inc.
Hazard

There is a potential for sterile package breach.

Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
Affected count
65 units
Manufactured in
4600 Nathan Ln N, Plymouth, MN, United States
Products
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2024

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