Penumbra Inc. is recalling its Penumbra 3D Revascularization device due to a risk of delivery wire breakage or separation during use, according to a July 21 U.S. Food and Drug Administration (FDA) release.
“Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces can make the stroke worse,” according to the FDA. “This can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.”
The FDA stated the recall affects four lots totaling 155 devices issued in the U.S. between May 15 and June 7. Penumbra sent an urgent voluntary removal notice to customers on June 9, asking them to remove the 3D revascularization devices from inventory and return them to the company.
This is a Class I recall, the most serious of three classifications, meaning it is designed for dangerous or defective products that could cause serious health problems or death.