Penumbra 3D Revascularization Device Recall Issued Over Fracturing Risk

A Class I recall has been issued for Penumbra Inc.’s 3D Revascularization Device, due to risks that the device may fracture during use, leaving pieces in a person’s brain or blood vessels. 

The Penumbra 3D Revascularization Device recall was categorized by the FDA last week as a class 1, meaning that continued use may result in severe injury or death.

The 3D Revascularization Device is a part of a full Penumbra System, which is used to restore blood flow to a blood vessel or remove a blood clot from a blood vessel in the brain during an acute ischemic stroke. It is typically used in patients who cannot have intravenous tissue plasminogen activator therapy.

In an Urgent Voluntary Removal notice Penumbra sent to customers on June 9, the company indicated the devices are being recalled because there is a risk the delivery wire may break or separate during use. Broken pieces of the delivery wire may then be inadvertently left inside the patient’s brain or blood vessel and travel through the bloodstream. This may cause the stroke to worsen.

Attempting to retrieve the pieces from the brain or the blood stream may also increase the severity of the stroke. The patient may also experience continued blood vessel blockage, a fully completed stroke, or in some cases death.

The notice identified the product in question and asks health care providers to remove the device from inventory completely.

Because of the severity of the side effects of the defect the FDA issued a class I recall, which is the most serious type of recall that can be issued. It is only issued when the device or drug has a high likelihood of causing serious injury or death to the patient.

Penumbra Inc. indicated health care providers who use the device, and all patients who may need to have the device used on them, should be aware of the recall.

Approximately 155 units were sold and recalled in the U.S. The devices were distributed from May 15, 2017, to June 7, 2017. The 3D Revascularization Devices were manufactured between March 31, 2017, to April 28, 2017.

Affected products were manufactured with lot numbers: C00644, C00645, C00646, and C00717.

Customers can contact the company to receive return instructions to send the affected device back to the company by calling 1-888-272-4606, or by email at RAQA@penumbrainc.com.

If a patient or health care provider experiences a side effect as a result of using the device they should contact the FDA’s MedWatch Adverse Event Reporting System online or by faxing 800-FDA-0178.