Medtronic Mo.Ma Ultra Proximal Cerebral Protection recall
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Why was Medtronic Mo.Ma Ultra Proximal Cerebral Protection recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 08033477090702:
- Product
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
- Recalling firm
- Medtronic Inc
- 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.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)