FDA Device recall Z-0623-2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile
- FDA Device
- Class II
- completed
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class II recall of Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile by Medtronic, citing seal defects could compromise the ability of the product packaging to maintain sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0623-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-11-20 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Reason
Seal defects could compromise the ability of the product packaging to maintain sterility.
Identifiers
| code_info | Lot number B644679, UDI-DI 00643169728974. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0623-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.