Class II
Medical Device Recall: Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Medtronic Inc. · February 16, 2024
Reason for Recall
There is a potential for sterile package breach.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
States Affected
NATIONWIDE
Quantity Affected
65 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1317-2024
Status: ongoing
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