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, a medical device placed in the brain to treat an aneurysm, has been recalled because the device may migrate inside the brain, causing a stroke, blood clot or even death.
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.
Class I recalls affect products with reasonable risk of serious adverse events or death with use.
Any customers with questions can call Penumbra, Inc. at 510-748-3224. Any health care professionals or consumers who have experienced an adverse event due to Penumbra Coil side effects should report it through the FDA MedWatch Safety Information and Adverse Event Reporting Program.