ClearanceBrief
Recall Z-0108-2026 ยท OUT Intracranial Aneurysm Flow Diverter

MICROVENTION INC.

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,

DateOct 10, 2025 (initiated Sep 5, 2025)
StatusOpen, Classified
ReasonFlow 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 causeDevice Design
ActionOn 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.
Quantity467
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.