Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Medical Device Caused Brain Damage, Lawsuit Alleges

The device may have been part of a previous recall by the FDA.

A Washington state man is suing Penumbra, claiming their Coil 400 medical device used to treat his aneurysm malfunctioned and caused him to suffer brain damage, according to the Associated Press.

According to the article, the lawsuit claims, "the doctor placed 90 percent of the coil into the aneurysm, but the last 10 percent got stuck in the intracranial artery."

The doctor was not able to remove the coil, which detached prematurely and remained, along with a stent, in the man's brain, causing him to suffer a stroke, according to the article.

In 2011, about 267 lots of Penumbra Coil 400 products were involved in a Class I recall by the FDA, who said, according to the article, "that it found that the pull wire on the delivery tool could slip out of place and allow premature detachment of the Coil 400."

A year later in 2012, the agency gave clearance to Penumbra to market the device again. The device in question was manufactured on Aug. 11, 2011 and had an expiration date of Aug. 31, 2013, according to the lawsuit.

The pateint's lawyer told the Associated Press, "they are trying to determine whether the device was one of the recalled coils, or if the new ones have the same problem."

Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report