Z-0108-2026Class II

Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526...

Name: Z-0108-2026 Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526...
Creator: Microvention Inc.
Published: 2025-09-05
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2025-09-05 / Open, Classified / root cause: design

FDA source

MICROVENTION INC. began a recall of Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014... on 2025-09-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0108-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-05
Posted: 2025-10-10
Recalling firm: Terumo Cardiovascular Systems Corporation
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
Product code: OUT Intracranial Aneurysm Flow Diverter
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 9/5/2025, recall notices were mailed to customers who were asked to do the following: 1) Stop using and quarantine affected devices. 2) Provide the notice to medical facilities or users to whom you have distributed recalled devices. 3) Return effected devices. 4) Complete and return the customer acknowledgement form via email to [email protected] Direct questions to the firm at [email protected] On 10/29/2025, additional recall notices were distributed identifying additional distributed devices.
Quantity in commerce: 467
Distribution: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0108-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0108-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10

Product code OUT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)