Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551

FDA device recall Z-0108-2026 · posted 2025-10-10 · Open, Classified

Recall details

Recalling firm

MICROVENTION INC.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

OUT

Quantity affected

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,

Date initiated

2025-09-05

Date posted

2025-10-10

Location

Aliso Viejo, CA