Recall Z-0321-2024 ยท NTE Temporary Carotid Catheter For Embolic Capture
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
| Date | Nov 17, 2023 (initiated Oct 12, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 173 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092177 | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 Invatec S.P.A., Oct 15, 2009 |