Medtronic has recalled a medical device used to treat brain aneurysms, a move that federal regulators this month classified as the most serious type of recall since there is a reasonable chance it could cause serious health problems or death.
A component of the medical device system can break off, which can also lead to strokes or other dangerous conditions, the Food and Drug Administration (FDA) said in a notice posted this month.
"There have been 59 reported device malfunctions, 10 serious injuries and two deaths related to this recall," the FDA notice says.
Medtronic sent a letter to doctors in July, telling them to stop using the devices and return them to the company. More than 8,800 had been distributed between April 2019 and August 2020.
With operational headquarters in Fridley, Medtronic said the recall was voluntary and that its letter to physicians was "an opportunity to raise further awareness of a potential safety issue."
"Through investigation we have established that the root cause of this delivery wire fracture is limited to a subset of devices," the company said in a statement to the Star Tribune. "Corrective actions have already been implemented to address the underlying issue causing the delivery wire fracture."
The recalled product, Medronic's Pipeline Flex Embolization Device, features a permanent mesh cylinder that's braided from metal wires and known as a stent. The risk stems from the guidewire system that doctors use to place the stent inside a patient's blood vessels.
Regulators say that, in some cases, the delivery system's wire and tubes may fracture and break off, and could be left inside the patient's bloodstream.
"It is also possible that attempts to retrieve the fractured pieces may make the patient's condition worse," the FDA notice states. "The fragments can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke and death."
Doctors use the Medtronic stents to treat brain aneurysms that bulge or balloon out of the sides of blood vessels. In its statement, the company said it takes the "potential risk seriously, and we are working to ensure all Medtronic customers are fully aware of the risk and associated mitigations."