Safety

MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use

[Posted 05/18/2018]

AUDIENCE: Cardiology, Risk Manager, Surgery

ISSUE: 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.

  • 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

BACKGROUND: The MindFrame Capture LP revascularization device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke in patients who are ineligible for or fail intravenous tissue plasminogen activator (IV t-PA) therapy

RECOMMENDATION: 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

    • 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.nvcomplaints@medtronic.com or by phone at 1(800) 633-8766.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/18/2018 - Medical Device Recall Communication - FDA]

 

Page Last Updated: 05/18/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English