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

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

No Comments

Leave a comment
Comment Information
Contact us

Contact Us - No Fee Until Recovery

Contact us to schedule a free initial consultation with our lawyer about your case. Personal injury cases are handled on a contingency fee basis. You pay no attorney fees until we recover a financial award for you. We can be reached at 216-931-0170. If you prefer, send us an email through our online contact form.

Bold labels are required.

Contact Information

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.


Privacy Policy

Firm Location

Piscitelli Law Firm
8440 Station St
Mentor, OH 44060

Phone: 216-931-0170
Fax: 216-931-9925
Mentor Law Office Map