A Class I medical device recall has been issued for the Penumbra Coil 400 system, which is used to treat brain aneurysms, because of defective delivery tool. Class 1 recalls are the U.S. Food & Drug Administration’s (FDA) most serious type of recall and involve situations in which there is a reasonable probability that a medical device will cause serious adverse health consequences or death.
The Penumbra Coil 400 is a small platinum coil placed into a brain aneurysm through the blood vessels leading to the brain. Once placed in the brain, a blood clot forms around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.
According to the recall notice, 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. This can result in migration of the coil, which can lead to serious injury including blood clot and stroke.
This recall involves 267 affected lots, F17211 to F18553, which were distributed in February 2011. 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.
According to Penumbra Inc., all affected units that were distributed both inside and outside the United States have been accounted for and returned to the company.
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