Penumbra Stent Retriever Recalled Due to Potential for Wire to Break, Separate

Certain lots of Penumbra’s 3D revascularization device, a stent retriever used to remove thrombus in the setting of acute ischemic stroke, have been recalled due to risk of breakage or separation of the delivery wire, the US Food and Drug Administration (FDA) announced Friday.

The recall, which was initiated in June, carries the FDA’s most serious Class I designation.

“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,” the FDA announcement states. “This can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.”

Penumbra sent its customers an Urgent Voluntary Removal notice on June 9 asking them to quarantine all affected devices, contact the company, and await instructions about returning and replacing them.

Affected devices come from four lots—C00644, C00645, C00646, and C00717—distributed between May 15 and June 7. The total number of recalled devices in the United States is 155.