Class II — Medtronic Inc.
| Recalling firm | Medtronic, Inc. |
|---|---|
| Registered facility | View this company's 53 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 23 devices |
| Distribution | US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO. |
| Initiated | 2021-03-16 |
| Classified | 2021-05-05 |
| Terminated | 2024-04-15 |
| Recall number | Z-1532-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic Inc. (Z-1532-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87638/
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