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U.S. Department of Health and Human Services

Medical Devices

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Penumbra Inc., Neuron 5F Select Catheter

Recall Class: Class I
Date Recall
Initiated:
May 29, 2009
Product:

Penumbra, Inc., Neuron 5F Select Catheter

The device was manufactured on or about May 26, 2009 and distributed from May 5, 2009 through June 12, 2009.

Use: The Neuron 5F Select Catheter is used to remove blood clots or foreign objects from blood vessels.
Recalling Firm: Penumbra, Inc.
1351 Harbor Bay Parkway
Alameda, California 94502-6541
Reason for Recall: 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.
Public Contact: The company may be contacted at 1-510-618-3223.
FDA District: San Francisco
FDA Comments:

On May 29, 2009, the company 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.

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.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.