Medtronic Inc Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Brand
Medtronic Inc
Lot Codes / Batch Numbers
UDI/DI 08033477090719: UDI/DI 00763000451691
Products Sold
UDI/DI 08033477090719: UDI/DI 00763000451691
Medtronic Inc is recalling Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026