Device 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.
Z-1532-2021
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 87638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 devices
- Official record key
device-enforcement:Z-1532-2021
Official wording
Reason: Incorrect size printed on the device; packaging is labeled correctly.
Code information: UDI 00643169796348, Lot Number B086915
Distribution pattern: US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
Derived failure modes
-
Unknown
Incorrect size printed on the device; packaging is labeled correctly.