Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled
Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device used in high-risk cerebral protection procedures. The labeling error directly affects safe device operation by potentially causing incorrect identification of balloon control ports, which could lead to serious patient harm. However, no injuries or deaths have been reported, making this a risk-of-harm product where injury has not yet been reported, meeting the High (Level 3) severity criteria.
Plain-English summary
Medtronic Inc has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5. This medical device is used for cerebral protection during vascular procedures.
The device manifold has two stickers that label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports—one label intended for each side of the manifold. In the recalled units, both sides were labeled with the superior label instead of having different labels on each side. This mislabeling could lead to incorrect identification of which ports control the proximal versus distal balloons when viewing the device from the inferior side.
The recall affects 48 units that were distributed worldwide. In the United States and in the following countries: Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, and the United Kingdom.
The recalled product
- Product
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
- Manufacturer
- Medtronic Inc
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI 08033477090696:
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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