Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
FDA device recall Z-0322-2024 · posted 2023-11-17 · Open, Classified
Recall details
- Recalling firm
- Medtronic Inc
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NTE
- Quantity affected
- 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.
- Date initiated
- 2023-10-12
- Date posted
- 2023-11-17
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 (K092177) | Invatec S.P.A. | 2009-10-15 |