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Penumbra 5F Select Catheters Named in Class I Recall

Sep 10, 2009 | Parker Waichman LLP A Class I recall has been issued for Neuron 5F Select Catheters made by Penumbra  Inc.  According to the recall notice, the catheters may contain pin holes and exposed wire braids.   Such a defect could result in  a brain clot or a blood vessel puncture, and this may lead to possible death.

Class I 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 injury or death.

The Neuron 5F Select Catheter is used to remove blood clots or foreign objects from blood vessels.  The device was manufactured on or about May 26, 2009 and distributed from May 5, 2009 through June 12, 2009.

According to the recall notice, on May 29, 2009, Penumbra notified their customers by telephone and email. They informed their customers about the problem and instructed them to return the product. All nine defective devices involved in this recall were returned to the firm and have been destroyed, the notice said.

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