Medtronic Mo.Ma Ultra Cerebral Protection Device Labeling Error
Medtronic is recalling 173 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to incorrect labeling that prevents proper identification of inflation and deflation ports on the device manifold.
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 classified as a risk-of-harm product (cerebral protection device) with a labeling error that could lead to incorrect device operation. No hospitalizations or injuries have been reported, placing it at High severity per the rubric.
Plain-English summary
Medtronic Inc. is recalling 173 units of the Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6. The affected devices were distributed worldwide to the United States and the following countries: Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, and the United Kingdom.
The device manifold is designed with two stickers to identify the inflation and deflation ports: a superior sticker labeling the common carotid artery (CCA) proximal balloon ports and an inferior sticker labeling the external carotid artery (ECA) distal balloon ports. The recalled units have both sides of the manifold labeled with the superior sticker instead of having one of each. This labeling error prevents correct identification of the proximal and distal inflation and deflation ports when viewing the device from the inferior side, which could lead to improper device operation.
The recalled product
- Product
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
- Manufacturer
- Medtronic Inc
- Affected units
- 173
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 08033477090702:
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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