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Medtronic Inc. recalls Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in t
Recalled May 12, 2021 · FDA recall Z-1532-2021 · Medtronic
Hazard
Incorrect size printed on the device; packaging is labeled correctly. · FDA Class II
Units
23 devices
Sold at
US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
Description
Incorrect size printed on the device; packaging is labeled correctly.
Product
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Manufacturer(s)
Medtronic Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →