Recall Z-0322-2024
Medtronic Inc · initiated October 12, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Codes / lots: UDI/DI 08033477090696:
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.
FDA-determined 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.
Details
- Recall number
- Z-0322-2024
- Initiated
- October 12, 2023
- Posted by FDA
- November 17, 2023
- Product code
- NTE – Temporary Carotid Catheter For Embolic Capture
- Quantity
- 48 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
- Recalling firm
- Medtronic Inc, Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0320-2024 Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each… | 10/12/2023Open, Classified |
| Z-0321-2024 Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each… | 10/12/2023Open, Classified |