The FDA recently issued a Class I medical device recall for the Penumbra Coil 400, which is used to treat brain aneurysms, reports say. The Class 1 recall is the most serous type of recall the FDA can issue.
The device is a small platinum coil which is placed into a brain aneurysm through the blood vessels leading to the brain, which then promotes a clot on the coil mass, occluding the aneurysm and protecting the blood vessel from rupturing.
But according to the recall, the system has a wire on it that is used as a delivery tool. The FDA is reportedly worried that the wire can slip out of place and allow the coil to become separated prior to placement.
In March, Penumbra, Inc. notified their customers and distributors and instructed them to return the product to the company. According to reports, Penumbra says all affected units were returned to the company and all are accounted for.
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