Class 1 Recall Issued for Penumbra Neuron 5F Select Catheter

Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels.

Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.

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.

SEPT-09-09: Class 1 Recall Issued for Penumbra Neuron 5F Select Catheter [FDA: PENUMBRA NEURON 5F SELECT CATHETER]

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Published on Sep-9-09