CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Flow Re-Direction Endoluminal Devices: FRED recalled by Microvention

Microvention is recalling Flow Re-Direction Endoluminal Devices: FRED 27, distributed nationwide in the US. The recall was initiated on 5 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/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/00842429114414(0000469603); FREDX5015-PMA/00842429114445(0000469606); FREDX5532-PMA/00842429114490(0000469610); FREDX4013-PMA/00842429114346(0000469613, 0000663758, 0000668189); FREDX3513-PMA/00842429114292(0000478834); FREDX4515-PMA/00842429114391(0000478840); FREDX3517-PMA/00842429114308(0000731304); MV-F352427X/04987892151101(0000760963)

Quantity recalled467

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0108-2026
FDA event ID: 97580
Recalling firm: Microvention, Aliso Viejo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Sep 2025
FDA classified: 10 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Sep 2025	Recall initiated by company
10 Oct 2025	Classified by FDA	+35 days
22 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL, CO, NE, NY and the countries of DE, ES, PL, GB, IT, IN, AU, KZ, JP, AT, SI, RS, GR, TR, AR, CH, SG, KR, SK, MX, DK, IR, SA, BY, PA, VN, ZA, BR, TW, CN, BE, FR, VE, MY.

Nationwide Arkansas California Colorado Florida Indiana Nebraska New York Pennsylvania South Carolina South Dakota Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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/00842429114414(0000469603); FREDX5015-PMA/00842429114445(0000469606); FREDX5532-PMA/00842429114490(0000469610); FREDX4013-PMA/00842429114346(0000469613, 0000663758, 0000668189); FREDX3513-PMA/00842429114292(0000478834); FREDX4515-PMA/00842429114391(0000478840); FREDX3517-PMA/00842429114308(0000731304); MV-F352427X/04987892151101(0000760963)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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