Penumbra Coil Recall: Aneurysm Device May Migrate in Brain

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 recall was announced by the FDA earlier this week. Penumbra Inc. notified its customers in March and the FDA has classified it as a Class 1 recall, meaning that the defective medical device has a reasonable probability of causing severe injury or death.

The Penumbra Coil 400 is a small platinum coil that is surgically implanted into a brain aneurysm via blood vessels leading to the brain. If implanted correctly, a blood clot forms around the coil, occluding the aneurysm and keeping the blood vessel from bursting.

However, the FDA warns that the Penumbra Coil system includes a tool for implanting the coil that is defective. A pull wire on the tool can slip out of place, resulting in the coil detaching from the tool prematurely. This allows the Penumbra Coil to migrate in the brain.

The recall affects 267 lots of the Penumbra Coil 400; from lot number F17211 to F18553. Penumbra Inc. has stated that it sent a letter to customers and distributors to return the products by mail and all of them have been accounted for and returned.

The Penumbra Coil was sold both inside and outside of the United States.

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.