Class I Recall - MindFrame Capture LP Revascularization Device by Medtronic
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
- Consider anti-platelet therapy
- Consider repeating imaging on the patient
- Complete and return the acknowledgement and receipt form to Medtronic
Customers with questions may contact Medtronic Quality Assurance by email at Rs.email@example.com 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.
Want to read the full alert and receive alert emails?