FRED Flow Re-Direction Endoluminal Device — Class II medical device recall Z-2238-2023
Ongoing recall by MICROVENTION INC., reported 2023-08-02, distributed nationwide. Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may no
| Recall number | Z-2238-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MICROVENTION INC., Aliso Viejo, CA, United States |
| Recall initiated | 2023-06-07 |
| Classified | 2023-07-27 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, BG, BR, CA, CL, CZ, DE, ES, FR, GB, IN, IR, JO, JP, KR, MA, MT, MY, PL, PT, SI, SV, TR, TW, UY, VN, ZA |
| Quantity | 474 |
| UPC / GTIN / UDI-DI | 00811425020982, 00811425021057, 00842429106655, 00842429106662, 00842429106679, 00842429106686, 00842429106709, 00842429106723, 00842429106730, 00842429106747, 00842429106754, 00842429106761, 00842429106778, 00842429106785, 00842429106808, 00842429106815, 00842429106822, 00842429106839, 00842429106846, 00842429106853, 00842429106860 |
| Lot numbers | 200702514, 20070256A, 20070256F, 20070256K, 20070256L, 20070256P, 20070256Q, 20070256R, 200702M6A, 200702M6Q, 200703558, 20070355A, 200703574, 200703575, 20070452X, 20070452Y, 20070654P, 200706563, 200706571, 200706M71, 200713549, 200713556, 2007135A3, 200713M49, 20071553E, 20071553L, 20071556Z, 20071557R, 20071557U, 200715M3L, 20071651L, 200716556, 200716562, 200716563, 200716565, 200716566, 200716M1L, 200717545, 200720563, 200721573 and 283 more |
| Model numbers | FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA and 21 more |
Product
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA, FRED4539-PMA, FRED5009, FRED5009-PMA, FRED5014-PMA, FRED5019-PMA, FRED5029, FRED5029-CA, FRED5029-PMA, FRED5514-CA, FRED5514-PMA, FRED5526-CA, FRED5526-PMA, MV-F351127, MV-F352427, MV-F401227, MV-F401727, MV-F451327, MV-F500927, MV-F501427, MV-F501927, MV-F552627
Reason for recall
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
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-2238-2023. 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.