Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
- Company
- Medtronic Inc
- Recall Initiated
- October 12, 2023
- Posted
- November 17, 2023
- Recall Number
- Z-0321-2024
- Quantity
- 173 units
- Firm Location
- Minneapolis, MN
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
Lot / Code Info
UDI/DI 08033477090702:
Root Cause
Process control
Action Taken
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.