FRED Flow Diverter (MicroVention) – Manufacturing Defect (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
MICROVENTION INC.
Lot Codes / Batch Numbers
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)
Products Sold
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)
MICROVENTION INC. is recalling Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED552 due to Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incomp. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Terumo8943@sedgwick.com Direct questions to the firm at terrence.callahan@microvention.com On 10/29/2025, additional recall notices were distributed identifying additional distributed devices.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026