Medtronic Inc: Mo.Ma Ultra Protection Device Recalled for Mislabeled Balloon Ports

Agency Publication Date: November 17, 2023

Summary

Medtronic has recalled approximately 2,988 Mo.Ma Ultra Proximal Cerebral Protection Devices because the manifold was manufactured with identical 'superior' labels on both sides. This labeling error causes the proximal and distal balloon inflation and deflation ports to be incorrectly identified when viewed from the inferior side. Healthcare providers using these devices in surgical procedures may inadvertently inflate or deflate the wrong balloon, which could lead to procedural complications or patient injury.

Risk

Incorrect identification of the arterial balloon ports can lead to improper inflation or deflation of the common carotid artery (CCA) and external carotid artery (ECA) balloons. This can result in failure to maintain necessary cerebral protection or unintended arterial occlusion during sensitive vascular procedures.

What You Should Do

Identify if you have the affected Medtronic Mo.Ma Ultra device by checking the model and UDI/DI numbers on the packaging: Model MUS0130069X6 (UDI 08033477090719 or 00763000451691), Model MOM0130069X6 (UDI 08033477090702), or Model MOM0130068X5 (UDI 08033477090696).
If you are a healthcare provider, immediately inspect your inventory for these specific model numbers and isolate any mislabeled units to prevent their use in clinical procedures.
Contact Medtronic Inc. at their Minneapolis headquarters at 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, MN 55432-5603 or through your local Medtronic representative for specific instructions on returning or correcting the affected devices.
Patients who have recently undergone a procedure involving a cerebral protection device should contact their healthcare provider if they have concerns or experience unusual symptoms.
For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and device management

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model MUS0130069X6

Model / REF:

MUS0130069X6

UPC Codes:

08033477090719

00763000451691

Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model MOM0130069X6

Model / REF:

MOM0130069X6

UPC Codes:

08033477090702

Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model MOM0130068X5

Model / REF:

MOM0130068X5

UPC Codes:

08033477090696

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93258

Status: Active

Manufacturer: Medtronic Inc

Sold By: Hospital supply chains; Medical device distributors

Manufactured In: United States

Units Affected: 3 products (2767 units; 173 units; 48 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if you have the affected Medtronic Mo.Ma Ultra device by checking the model and UDI/DI numbers on the packaging: Model MUS0130069X6 (UDI 08033477090719 or 00763000451691), Model MOM0130069X6 (UDI 08033477090702), or Model MOM0130068X5 (UDI 08033477090696).

If you are a healthcare provider, immediately inspect your inventory for these specific model numbers and isolate any mislabeled units to prevent their use in clinical procedures.

Contact Medtronic Inc. at their Minneapolis headquarters at 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, MN 55432-5603 or through your local Medtronic representative for specific instructions on returning or correcting the affected devices.

Patients who have recently undergone a procedure involving a cerebral protection device should contact their healthcare provider if they have concerns or experience unusual symptoms.

For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model MUS0130069X6

Model / REF:

MUS0130069X6

UPC Codes:

08033477090719

00763000451691

Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model MOM0130069X6

Model / REF:

MOM0130069X6

UPC Codes:

08033477090702

Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model MOM0130068X5

Model / REF:

MOM0130068X5

UPC Codes:

08033477090696