Z-1532-2021 Class II Terminated
FDA device recall Z-1532-2021 was initiated by Medtronic Inc. on March 16, 2021 and is designated Class II. Reason for recall: Incorrect size printed on the device; packaging is labeled correctly. The recall status is terminated (terminated April 15, 2024). Affected quantity: 23 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 12, 2021
- Initiation Date
- March 16, 2021
- Termination Date
- April 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 devices
Product Description
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 Pattern
US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
Code Information
UDI 00643169796348, Lot Number B086915