FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352

FDA device recall Z-2238-2023 · posted 2023-07-27 · Open, Classified

Recall details

Recalling firm

MICROVENTION INC.

Reason for recall

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

Action taken

On 6/7/23 recall notices were emailed to customers who were asked to stop use, quarantine, and return affected devices. Follow-up notices were mailed to customers on 6/16/23. Customers were asked to share the notice with all device users within the facility and network and share the notice with any organization where potentially affected devices have been transferred. In addition, customers were asked to complete and return the customer acknowledgement form. Inquiries can be directed to customer service at 800-990-8368.

Root cause

Process control

Status

Open, Classified

Product code

OUT

Quantity affected

474

Distribution

Worldwide - US Nationwide distribution including in the states of AZ, NY, FL, CA, PA, SC, TX, IL, MA, NJ, VA, GA, OH, IN, MI, KY, AL, MO, SD, LA, WA, HI, KS, MD, OK, DE, NC, MS and the countries of Ta

Date initiated

2023-06-07

Date posted

2023-07-27

Location

Aliso Viejo, CA