Class I Recall - MindFrame Capture LP Revascularization Device by Medtronic

PUBLISHED: May 18, 2018
Relevant to: Critical Access Hospitals, Hospitals

The FDA has issued a Class I Recall of Medtronic's MindFrame Capture LP Revascularizatin Device. A Class I recall is the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product: The MindFrame Capture LP revascularization device

Product Lot Numbers: 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018

Distribution Dates: March 18, 2016 to January 17, 2018

Manufacturing Dates: February 3, 2016 to January 14, 2018

Devices Recalled in the U.S.: 529 nationwide

Reason for Recall

Medtronic is recalling the MindFrame Capture LP revascularization device because there is a risk of the delivery wire breaking or separating during use. The clot retriever could be left inside the patient's bloodstream, and this or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death.

What to Do

On February 26, 2018, Medtronic sent an Urgent Medical Device Recall Notice to all affected customers and asked them to remove any affected MindFrame Capture LP Revascularization devices from inventory and quarantine them. The notice also requested customers return the affected products to Medtronic.

On April 4, 2018, Medtronic followed up with their customers with another Urgent Medical Device Recall notice regarding patient management. The notice recommended health care providers to:

  • Review the notification and distribute the information to all appropriate personnel
  • Follow up with the patient closely and
  • Complete and return the acknowledgement and receipt form to Medtronic

Contact Information

Customers with questions may contact Medtronic Quality Assurance by email at Rs.nvcomplaints@medtronic.comor by phone at 1(800) 633-8766

Date Recall Initiated

February 26, 2017

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

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