FDA Device recall Z-1532-2021
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral vein…
- FDA Device
- Class II
- terminated
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral vein… by Medtronic, citing incorrect size printed on the device; packaging is labeled correctly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1532-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-16 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | US |
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
Incorrect size printed on the device; packaging is labeled correctly.
Identifiers
| code_info | UDI 00643169796348, Lot Number B086915 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1532-2021%22
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