The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential for serious injury or death.
The Fridley, Minn.-based company’s MindFrame Capture LP device is designed to restore blood flow and remove blood clots within a blood vessel in the brain during acute ischemic stroke in patients who are ineligible or fail intravenous tissue plasminogen activator therapy.
Medtronic initiated the recall due to a risk of the delivery wire breaking or separating during use, which could leave the clot retriever inside a patient’s blood vessels. Both the device being left and attempts to retrieve the device can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms or death, according to the FDA release.
A total of 529 units with lot numbers between 300010 and 300018 are affected by the recall, manufactured between February 3, 2016 and January 14, 2018 and distributed between March 18, 2016 and January 17, 2018, according to the FDA recall notice.
Medtronic began notifying customers of the issue in late February, and followed up last month recommending that healthcare providers consider alternative therapies and quarantine and return affected products to the company.