Recall Z-0321-2024— Medtronic Inc
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc, initiated 2023-10-12. It names one FDA 510(k) clearance: K092177. Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6. Reason: 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..
- Recalling firm
- Medtronic Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-12
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.