Medtronic recalls Mo.Ma Ultra Proximal Cerebral Protection Device model MOM0130068X5 due to incorrect port labeling that may cause misidentification during use. Affected units have superior labels on both sides of the manifold.
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.
Medtronic is recalling a specific cerebral protection device model because its port labels are incorrectly placed. This could lead to misidentifying which ports inflate or deflate blood vessels during surgery, potentially causing complications.
The device's manifold has two stickers that label the blood vessel ports. In affected units, both sides show the superior label instead of the correct combination. This could cause the surgical team to use the wrong ports during procedures, potentially leading to incorrect blood vessel inflation or deflation.
Surgical teams using the Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device model MOM0130068X5 are most at risk. This recall affects devices sold with the unique identifier 08033477090696.
Check for the model number MOM0130068X5 on the device. Affected units have the unique identifier 08033477090696. The device is labeled with two stickers on the manifold, but both sides show the superior label.
Look for the model number MOM0130068X5 and unique identifier 08033477090696 on the device.
The device has incorrect port labeling that could lead to misidentifying blood vessel inflation and deflation ports during surgery.
Check for the model number MOM0130068X5 and unique identifier 08033477090696. Affected units show the superior label on both sides of the manifold.
The recall does not require immediate action, but you should check the device labels to confirm if it is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0322-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0322-2024 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
