FDA Announces Recall of Penumbra Catheters Used in Stroke Procedures

The U.S. Food and Drug Administration (FDA) recently announced the recall of Penumbra Jet 7 Xtra Flex catheters because they may pose a risk of serious injury. The FDA has received over 200 medical device reports associated with the devices, including deaths, serious injuries, and malfunctions.

What Is the Penumbra System?

The Penumbra System is designed specifically to facilitate a procedure called a “mechanical thrombectomy.” This is a type of minimally invasive procedure in which an interventional radiologist uses specialized equipment—in this case, made by Penumbra—to remove a blood clot from a patient’s artery.

A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing the brain tissue from getting the oxygen and nutrients it needs to function properly. Brain cells can begin to die in minutes, so immediate treatment is critical.

The most common type of stroke is called an “ischemic stroke,” and occurs when the brain’s blood vessels become narrowed or blocked, often because of a blood clot. A mechanical thrombectomy may be used to remove the clot and restore blood flow once again.

There are currently two ways to perform a mechanical thrombectomy:

  1. Use of a stent retriever
  2. Use of aspiration

For the first option, the radiologist makes a small incision in either the wrist or abdomen, threads a catheter through the artery to the clot, then inserts a tiny net-like device called a “stent retriever.” Once in place, that retriever expands to the size of the artery wall, capturing the clot so the radiologist can pull it out.

For the second option, the radiologist proceeds in much the same way, except instead of using a stent retriever to grasp and remove the clot, the radiologist uses an aspiration catheter that uses suction to remove it.

The Penumbra System uses the second option, stating on its website that it is engineered for “quick and effective clot removal,” with “nearly pure vacuum power” to capture clots.

Why Were the Penumbra Catheters Recalled?

This particular recall affects the following Penumbra devices:

  • The JET 7 Xtra Flex Catheter
  • The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and Max Delivery Device)

As part of the Penumbra System with the Penumbra Aspiration Pump and Aspiration Tubing, these catheters are intended to help restore blood flow by removing clots using continuous aspiration (sucking action). The FDA has received over 200 reports, however, of these devices ballooning, expanding, rupturing, breaking, or separating, exposing the patient to the internal support coils near the tip of the catheter.

When the catheters malfunction this way during a mechanical thrombectomy, it puts the patient at risk. Reports describe serious patient injuries such as vessel damage, hemorrhage, and cerebral infarction (stroke).

When the manufacturer tested the products, the results showed that the Jet 7 Xtra Flex catheter was not able to withstand the same burst pressures as the manufacturer’s other large-bore aspiration catheters used to remove blood clots in stroke patients.

Penumbra reports it is aware of a total of 17 events involving patient injury and 14 deaths related to distal tip damage, including damage related to expansion or rupture. Because of these failures, Penumbra initiated a voluntary recall of all configurations of these catheters from the market on December 15, 2020. The company has notified doctors and medical centers of the recall and directed them to return the affected units for a replacement or refund.