Flow Re-Direction Endoluminal Devices: FRED 27 — Class II medical device recall Z-0108-2026
Ongoing recall by MICROVENTION INC., reported 2025-10-22, distributed nationwide. Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern
| Recall number | Z-0108-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MICROVENTION INC., Aliso Viejo, CA, United States |
| Recall initiated | 2025-09-05 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 467 |
| UPC / GTIN / UDI-DI | 00811425020388, 00811425020395, 00811425020425, 00811425021033, 00842429107508, 00842429107553, 00842429107560, 00842429107577, 00842429107638, 00842429114292, 00842429114308, 00842429114315, 00842429114346, 00842429114391, 00842429114414, 00842429114445, 00842429114483, 00842429114490, 00842429117002, 00842429117019, 00842429117033, 00842429117095, 00842429117156, 00842429117163, 00842429117170 and 5 more |
| Lot numbers | 0000469609, 0000531733, 0000663758 |
| Model numbers | FRED3511, FRED3516, FRED3536, FRED4026, FRED4508, FRED4528, FRED5014, FRED5019, FRED5029, FRED5514, FRED5526, FREDX3513-PMA, FREDX3517-PMA, FREDX3522-PMA, FREDX4013-PMA, FREDX4515-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5522-PMA, FREDX5532-PMA, MV-F352427X, MV-F451827, MV-F501427X, XFRED4017-MVE, XFRED4518-MVE and 3 more |
Product
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X
Reason for recall
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0108-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.