Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled
Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.
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: FDA Class II medical device with labeling error affecting critical port identification on a cerebral protection device. Per the rubric, this is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device (Model Number MUS0130069X6) due to a labeling error on the device manifold affecting port identification.
The device manifold is designed to be labeled with two stickers—one on the superior side and one on the inferior side—to identify the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. In the recalled units, both sides of the manifold were incorrectly labeled with the superior sticker. This results in incorrect identification of the proximal and distal ports when viewed from the inferior side.
The affected devices were distributed worldwide, including the United States and Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and patients with these devices should contact Medtronic Inc. for guidance on this recall.
The recalled product
- Product
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
- Manufacturer
- Medtronic Inc
- Affected units
- 2,767
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 08033477090719: UDI/DI 00763000451691
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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