FDA Recalls Penumbra Aneurysm Coil–Potential to Detach & Migrate Causing a Stroke or Blood Clots While Being Patient Is Be
Posted Apr 19 2011 10:04pm
If one were being treated for a brain aneurysm, this is the last thing I would want to hear. I remember when I sad 2 years ago that recalls on both drugs and devices was going to grow at a phenomenal rate and look what we have today and no system. It’s not that I’m so smart it’s just the technology is out there today first of all to find defective devices soon and the fact that so many are made outside the direct control of a company, things happen. Where we suck at the FDA is a system to alert and make sure the products are not use. See the bar code section above for the complete doable details with bar codes. That happens more than you think and people have died when recalled products are missed from being pulled and used in error. BD
WASHINGTON -- The FDA upgraded the recall of the Penumbra platinum coil for treating brain aneurysms to class I due to the potential for the device to detach and migrate, which can lead to stroke.
The Penumbra Coil 400 recall includes 267 lots -- F17211 to F18553 -- distributed in February 2011, according to an FDA statement.
The small coil is placed into a brain aneurysm by threading it through blood vessels leading to the brain. Once in place, a clot forms around the coil mass, occluding the aneurysm and protecting the vessel from ruptures or leaks.
The recalled device has a pull wire attached to an included tool used to implant the coil. The wire can slip and allow the coil to detach prematurely, migrating to unaffected areas to potentially cause serious injury, including blood clots and stroke, the FDA said.
The coil's manufacturer, Penumbra of Alameda, Calif., initiated the recall on March 4, 2011 notifying customers and distributors of the problem by mail, with instructions to return the recalled product to the company.
The affected product was half-distributed in the U.S. and half-distributed internationally, the agency statement said.