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FDA Class I Recall of a Medical Device Penumbra Inc. 3D Revascularization Device

Penumbra Inc. 3D Revascularization Device has been Recalled Due after discovery that the Wire Material May Break or Separate during Use, Leaving Pieces in the Patient Brain Bloodstream

fda device recall

The Penumbra Inc. 3D Revascularization Device is intended to restore blood flow or remove thrombus (blood clot) within a blood vessel in the brain.

According to the FDA Recall, physicians that are using the devices impacted by the recall should immediately STOP using the device, as it puts patients at risk for serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.

The FDA Recall explains that the Penumbra Inc. 3D Revascularization Device is the subject of a Class I, FDA Recall, the most serious type of recall issued by the agency, due to the failure of a delivery wire that is inserted into the brain to restore or remove a blood clot that may break while in use. Specifically, the FDA identified that there is a risk of the delivery wire breaking or separating, which could leave fractured pieces of the delivery wire inside the patient’s brain bloodstream. If this occurs or if attempts are made to retrieve the fractured pieces, the patient’s condition can get worse and can cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.

The information for the recalled Penumbra 3D Revascularization Device is listed below, it is estimated to include 155 of the Penumbra 3D Revascularization Devices nationwide. The FDA initiated the recall on June 8, 2017.

The following day, June 9, 2017, the manufacture of the device, Penumbra Inc., sent an Urgent Voluntary Removal notice to all affected customers whose medical facilities utilize the Penumbra 3D Revascularization Device.

If you think that you or someone in your family has been suffered serious adverse health consequences or died after a medical procedure involving a Penumbra 3D Revascularization Device, please contact our offices to discuss your claims.

Recalled Product Information
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

To read the FDA Recall related to this product click here, https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm567913.htm