Penumbra Inc., Penumbra Coil 400
Recall Class: Class I
Date Recall Initiated: 3/4/11
Product: Penumbra Coil 400
Affected Lots: F17211 to F18553
The 267 affected lots were distributed in February 2011. According to the company, all affected products have been accounted for and returned.
Use: The Penumbra Coil 400 is a small platinum coil placed into a brain aneurysm through the blood vessels leading to the brain. Once the device is in place, the body responds by forming a blood clot around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.
1351 Harbor Bay Parkway
Alameda, California 94502-6541
Reason for Recall: The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.
Public Contact: Questions may be directed to Wendy Ruiz of Penumbra, Inc. at (510) 748-3224.
FDA District: San Francisco
On March 4, 2011, Penumbra, Inc. notified their customers and distributors of the recall by mail. The letter described the reason for recall and customers were instructed to return the product to the company.
Penumbra has stated that all affected units that were distributed both inside and outside the United States have been accounted for and returned to the company.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.