Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 08033477090719: UDI/DI 00763000451691
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Product Codes/Lot Numbers:
UDI/DI 08033477090719: UDI/DI 00763000451691
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0320-2024
Related Recalls
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.