FDA said 155 devices on the U.S. market are included in a recall of Penumbra's 3D Revascularization device because the delivery wire could break or separate during use.
Penumbra initiated a voluntary recall of its Penumbra 3D Revascularization device because of a risk that the delivery wire could break or separate during use.
FDA classified a recall of the Penumbra 3D Revascularization device as a Class I recall, the agency's most serious type of recall. The device is designed to restore blood flow or remove a clot within a blood vessel in the brain during an acute ischemic stroke. It is used in patients who are ineligible for or fail intravenous tissue plasminogen activator (IV t-PA) therapy.
Penumbra voluntarily pulled the device from the market based on concern that the delivery wire could break or separate during use, and that fractured pieces of the wire could be left inside the patient's brain bloodstream. If this happened, FDA noted, it could make the stroke worse, or it could lead to the completion of the stroke or death.
The company has had similar problems with its technology before. In 2011 Penumbra recalled its Penumbra Coil 400 because the pull wire on the delivery tool was at risk of slipping out of place and allowing the coil to detach from the delivery device prematurely. At least one patient ended up suing the company. According to the patient, who was treated for a brain aneurysm in 2013, when the device was placed into the aneurysm 10% remained stuck in the intracranial artery. His lawyer said the device detached prematurely, leaving fragments of it lodged in his brain, which later caused him to have a stroke.
[Image credit: FDA]