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Date: 9/18/2009 2:49:34 PM

Penumbra Neuron 5F Select Catheter

REASON: 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.

distribution: nationwide.

Audience: Neurosurgical and invasive radiology healthcare professionals, hospital risk managers

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.

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA''s MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

[09/09/2009 - Recall Notice - FDA]

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