Medtronic recalls Mo.Ma Ultra Proximal Cerebral Protection Device model MUS0130069X6 due to incorrect labeling of arterial inflation ports, potentially causing misidentification during medical procedures.
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 labeling could lead to incorrect identification of arterial inflation ports during medical procedures. This risk may cause errors in critical surgical steps if the device is used without proper identification.
The device has two stickers on the manifold that label arterial inflation ports. If the superior sticker is used on the inferior side, the device may be misidentified during surgery, potentially causing incorrect placement of the device in the patient's blood vessels.
Medical professionals using the recalled device model are most at risk. Patients receiving this device during surgery may be affected if the labeling error leads to incorrect placement.
Check for the model number MUS0130069X6 on the device. The recall includes devices with UDI/DI numbers 08033477090719 and 00763000451691.
Verify the presence of both superior and inferior stickers on the manifold to ensure correct labeling of arterial inflation ports.
The recall is for labeling errors, not the device itself. If labeled correctly, the device is safe for use.
Check the model number and UDI/DI numbers on the device to see if it's affected. Contact Medtronic for further instructions.
Look for the model number MUS0130069X6 and UDI/DI numbers 08033477090719 or 00763000451691 on the device.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0320-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0320-2024 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.
