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RecallWatchMedical Device Safety
Class IIOngoingZ-0108-2026

MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27

MICROVENTION INC.Aliso Viejo, CA, United StatesReported Oct 22, 2025 · 8 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Flow Re-Direction Endoluminal Devices: FRED 2712 codes
  • FRED5019
  • FRED5029
  • FRED4528
  • FRED4026
  • FRED5526
  • FRED4508
  • FRED5514
  • FRED3536
  • FRED3511
  • FRED5014
  • FRED3516
  • MV-F451827
FRED X 2716 codes
  • 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

Lot / code information

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 — +9 moreShow all
): 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)

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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