FDA recall Z-1532-2021

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.

Reason for recall

Incorrect size printed on the device; packaging is labeled correctly.

Distribution

US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.

Key facts

Status

Terminated

Initiation date

2021-03-16

Report date

2021-05-12

Termination date

2024-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1532-2021