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 | Ongoing |
| Reason | Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. |
| Product | EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System |
| Quantity | 183964 devices |
| Distribution | worldwide |
| Initiated | 2022-07-14 |
| Classified | 2022-08-26 |
| Recall number | Z-1644-2022 |
| 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-1644-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90652/
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