Friday, September 11, 2009
Penumbra Announces Recall of the Neuron 5F Select Catheter that May Result in Brain Clots, Blood Vessel Puncture or Death
Neuron 5F Select Catheter Recall:
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].
CONTACT INFORMATION: If you or a family member have been injured or damaged due to the fault or responsibility of someone else, an industrial accident or by a dangerous or defective product, drug or toxic substance, contact Alan Morton for a no obligation, free consultation.
For additional information contact:
Alan L. Morton
MORTON LAW OFFICES, CHARTERED
1005 North Eighth Street
Post Office Box 420
Boise, ID 83701-0420
Toll Free: 866.946.1669 [866.WIN.1.NOW]