Medtronic MindFrame Capture LP Revascularization Device Wire May Break, Separate During Use: Recall

Federal health officials indicate that certain recalled Medtronic revascularization devices, which are used to remove blood clots within the brain’s blood vessels, have delivery wires that may break or separate during surgical procedures, posing a risk of serious adverse health consequences or death. 

A class 1 Medtronic Mindframe Capture LP recall was announced by the FDA on May 18, after determining the revascularization device wires may break or separate during use, resulting in a risk of bleeding events or further blockages.

The recall involves revascularization devices intended to restore blood flow or remove blood clots within a blood vessel in the brain during ischemic stroke events for patients unable to receive intravenous tissue plasminogen activator therapy.

Did You Know?

Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

The Class I designation indicates that the product causes a situation which there is a reasonable probability that the use or exposure could cause serious adverse health consequences or death.

The FDA assigned the highest classification to the recall because the clot retriever could be left inside the patients’ bloodstream, and cause further blockages. Attempts to remove the detached delivery wire could cause further complications including bleeding, blocked blood vessels, more severe stroke symptoms, or death.

The recalled MindFrame Capture LP revascularization devices were manufactured from February 3, 2016 through January 14, 2018 by Medtronic Equipment Company of Minneapolis, Minnesota. Recalled devices are marked with Lot numbers 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018. The devices were distributed to hospitals and medical facilities nationwide from March 18, 2016 through January 17, 2018.

According to the FDA recall notice, approximately 529 recall devices were distributed for sale throughout the United States.

Medtronic released an Urgent Medical Device Recall Notice to all of its affected customers describing the issue and instructing customers to remove any of the devices from use and quarantine them.

Customers with additional questions concerning the recall should contact Medtronic at 1-800-633-8766 or visit them online at


"*" indicates required fields

Share Your Comments

I authorize the above comments be posted on this page*

Have Your Comments Reviewed by a Lawyer

Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Bard Argues Hernia Mesh Lawsuits Previously Selected for Bellwether Trials Are No Longer
Bard Argues Hernia Mesh Lawsuits Previously Selected for Bellwether Trials Are No Longer "Representative" (Posted 2 days ago)

Bard claims two cases selected for the third and fourth bellwether trials are no longer representative of the litigation due to the plaintiffs' worsening injuries and need for additional surgeries due to their failed hernia mesh products.