—#203779

Product

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

FDA product code: NTE — Temporary Carotid Catheter For Embolic Capture
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K092177
Affected lot / code info: UDI/DI 08033477090702:

Why it was recalled

The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.

Root cause (FDA determination)

Process control

Action the firm took

Medtronic issued an URGENT: MEDICAL DEVICE RECALL NOTIFICATION on 10/04/2023 via UPS. The notice explained the issue, potential risk, and requested the return of the device. For questions, consignees were directed to contact their Medtronic Field Sales Representative.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.

Timeline

Recall initiated: 2023-10-12
Posted by FDA: 2023-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203779. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.