The Food And Drug Administration (FDA) has ordered the recall of the MindFrame capture LP revascularization device manufactured by Medtronic, a healthcare company involved in medical technology, services and solutions located in Minneapolis, Minnesota with corporate headquarters in Dublin, Ireland.
The action is classified as a Class 1 Recall, which is the most serious type. The company is complying with the recall and sent an urgent medical device recall notice to affected parties in February and issued another urgent medical device recall in April.
About 529 devices have been recalled in the United States.
In the second notice, Medtronic urged healthcare providers to follow up with patients and to consider the use of blood thinner medications and repeat imaging of patients.
The MindFrame Capture LP revascularization device is used to restore blood flow or remove blood clots in blood vessels in the brain during an acute ischemic stroke. An ischemic stroke is the most common stroke and is caused by a blood clot that blocks or plugs a blood vessel in the brain, preventing blood from flowing to the brain. The device is used on patients who are ineligible for or fail treatment using intravenous tissue plasminogen activator therapy.
The Medtronic medical device has been recalled due to the risk of the breaking or separation of the delivery wire. Such an occurrence could result of the clot retriever being left inside the patient’s bloodstream. This or attempts to remove the device can cause more complications including bleeding, additional blockage of blood vessels, a more severe stroke, or even death.
People affected by the Medtronic recall include healthcare professionals who install the device during revascularization procedures or patients who undergo procedures using the Medtronic medical device.
The FDA recall provided information concerning the Medtronic devices recalled including product name, lot numbers and manufacturing and distribution dates. According to the agency:
- • Lot numbers are 300010 through 300018
- • The date of manufacturing was February 3, 2016 to January 14, 2018
- • Distribution dates were March 18, 2016 to January 17, 2018
Patients or their families who have questions should contact Medtronic Quality Assurance by email at Rs.email@example.com or call (800) 633-8766.
The company also recommends that healthcare professionals and patients report any adverse events or side effects caused by the use of the Medtronic MindFrame Capture LP revascularization device to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.
The report can be submitted online at:
You can also download the form at:
Or call 1-800-332-1088 to request a form. Complete it and return to the address on the form or submit via fax to 1-800-FDA-0178.
If you or a loved one have been the victim of a defective Medtronic recall device, please contact us. The Eichholz Law Firm can assist in advising you what to do and guide you through a lawsuit for compensation for your suffering. Our staff of attorneys are knowledgeable and skilled in these types of suits and are ready to help.