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U.S. Department of Health and Human Services

Class 2 Device Recall Mo.Ma" Ultra Proximal Cerebral Protection Device

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 Class 2 Device Recall Mo.Ma" Ultra Proximal Cerebral Protection Devicesee related information
Date Initiated by FirmOctober 12, 2023
Date PostedNovember 17, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0321-2024
Recall Event ID 93258
510(K)NumberK092177 
Product Classification Temporary Carotid Catheter for Embolic Capture - Product Code NTE
ProductMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Code Information UDI/DI 08033477090702:
FEI Number 3001504994
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
For Additional Information ContactPVH Customer Service
800-716-6700
Manufacturer 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 2		Process control
ActionMedtronic 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 in Commerce173 units
DistributionWorldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NTE
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