FDA Device recall Z-0108-2026
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED35…
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED35… by Microvention, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0108-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-05 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microvention |
| Distribution | US |
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
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.
Identifiers
| code_info | REF/UDI-DI(Lot): FRED5019/00811425020388(0000235839), 00842429117163(0000544498); FRED5029/00811425020395(0000256343),…REF/UDI-DI(Lot): FRED5019/00811425020388(0000235839), 00842429117163(0000544498); FRED5029/00811425020395(0000256343), 00842429117170(0000507209); FRED4528/00811425020425(0000265666); FRED4026/00811425021033(0000333125, 0000576973); FRED5526/00842429117194(0000361117); FRED4508/00842429117095(0000372088); FRED5514/00842429117187(0000429786, 0000478385); FRED3536/00842429117033(0000460268, 0000445555); FRED3511/00842429117002(0000452923); FRED5014/00842429117156(0000563591, 0000464401); FRED3516/00842429117019(0000513146, 0000531733, 0000536217); MV-F451827/04987892121906(0000565094); XFRED4017-MVE/00842429107508(0000478838); XFRED4528-MVE/00842429107560(0000518323, 0000663751); MV-F501427X/04987892151231(0000579031); XFRED4518-MVE/00842429107553(0000663074, 0000663750); XFRED5526-MVE/00842429107638(0000704203); XFRED4539-MVE/00842429107577(00007311620); FREDX5522-PMA/00842429114483(0000265641, 0000469609, 0000731155); FREDX3522-PMA/00842429114315(0000469598); FREDX4525-PMA/00842429 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0108-2026%22
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