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WARNING – Class I recall (the most serious of three classifications)

Posted by Frank Piscitelli | Jul 26, 2017 | 0 Comments

Penumbra Inc. is recalling its Penumbra 3D Revascularization device due to a risk of delivery wire breakage or separation during use, according to a July 21 U.S. Food and Drug Administration (FDA)release.

“Fractured pieces of the delivery wire could be left inside the patient's brain bloodstream, and this or the attempts made to retrieve the fractured pieces can make the stroke worse,” according to the FDA. “This can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.”

The FDA stated the recall affects four lots totaling 155 devices issued in the U.S. between May 15 and June 7. Penumbra sent an urgent voluntary removal notice to customers on June 9, asking them to remove the 3D revascularization devices from inventory and return them to the company.

This is a Class I recall, the most serious of three classifications, meaning it is designed for dangerous or defective products that could cause serious health problems or death.

Penumbra 3D Revascularization Device

Lot Numbers: C00644, C00645, C00646, C00717

Distribution Dates: May 15, 2017 to June 7, 2017

Manufacturing Dates: March 31, 2017 to April 28, 2017

Devices Recalled in the U.S.: 155 nationwide

About the Author

Frank Piscitelli

As a first-generation Italian in the United States, Frank is no stranger to tough times. His father's family moved to Cleveland from Italy on May 22, 1958, with a few articles of clothing, some personal items and very little money. His family shared a home with three other related families but happily worked long hours doing jobs that involved physical labor, just to put food on the table. There was the promise of hope and opportunity, which was missing before his family moved here.

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Attorney Frank Piscitelli has nearly 30 years experience representing individuals and families against large corporations and insurance companies. His practice is limited to wrongful death and very serious injury cases.

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