The Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology was recalled in December 2020 due to numerous reports of injuries and deaths. Although the FDA recall prevents future injuries, the device was on the market for long enough to injure and kill several patients.

Despite its deadly reputation, the Penumbra Reperfusion Catheter was designed to save lives — specifically those of patients suffering from an acute ischemic stroke.

These strokes are caused by a blood clot blocking blood flow to the brain and are the most common type of stroke. In order to resolve the blockage, revascularization is required. This can be done through an IV drug that breaks down the clot or through manual removal using a device such as the Penumbra catheter.

The Penumbra catheter defects reportedly cause the device’s tip to balloon, expand, rupture, break, completely separate, or even expose internal support coils. These defects can lead to patient injuries such as vessel damage, hemorrhaging, and continued blockage of blood vessels. In some situations, these complications can be deadly.

FDA Reports of Penumbra Catheter Deaths

There have been several reports of Penumbra catheter deaths filed with the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. These reports detail concerning issues with the catheter involving failure or inability to work properly – both leading to patient deaths.

The first MAUDE report of death involving a Penumbra catheter occurred in June 2019. According to the report, the Penumbra catheter fractured while the physician was maneuvering the device through the patient’s blood vessels, and the fractured tip was unable to be removed and the patient later died.

Since the initial report of death in 2019, the FDA has received 20 other reports of death involving the Penumbra Jet7 catheter. Other deaths may have occurred, as this figure only indicated the number of reports in the MAUDE database.

These numerous reports detail situations similar to the initial death report. In May 2020, one doctor detailed their experiences with the Penumbra catheter which reportedly led to patient death.

While attempting to remove the clot from a patient’s brain, the tip of the Penumbra catheter allegedly expanded and broke off, hanging on only be a coil wind. Shortly after, one of the largest blood vessels in the patient’s brain ruptured. Unfortunately, due to the broken tip of the catheter, a balloon catheter couldn’t be used to stop the bleeding.

To make matters worse, the doctor reportedly experienced difficulties removing the Penumbra catheter due to the broken tip, forcing the doctor to take additional steps to access the steadily bleeding ruptured blood vessel. After 48 hours and poor neurological examinations, care was withdrawn from the patient – leading to the patient’s death.

Penumbra previously made attempts to warn physicians of the issue after numerous deaths were reported. In July 2020, before recalling the product completely, Penumbra sent a notification to healthcare providers noting that using the catheter to inject contrast dye or using the device in conjunction with other manufacturers’ revascularization devices was not recommended. The manufacturer noted that this usage could cause the tip of the catheter to expand or rupture – as reported in numerous MAUDE reports.

Several reports of death were filed with the FDA before this notification was released to healthcare providers. One report from July 2020 explains that the patient’s artery ruptured after contrast dye was injected through the Penumbra catheter – leading to the patient’s death.

The most recent MAUDE report was from late October 2020 from a physician who attempted revascularization using the Penumbra catheter. The patient’s blood clot was unable to be removed as intended, causing the physician to remove the device from the patient, according to the doctor’s report. Upon inspection, the physician reportedly discovered that the “coil winds” on the device had become exposed near the end of the catheter.

Worried about how this may have impacted the patient, the doctor says that they checked the patient’s status through contrast imaging – only to find an abnormal connection between the two blood vessels near the brain causing a brain bleed. Although the doctor was able to stop the bleed, the patient’s underlying stroke reportedly worsened as it was unable to be resolved using the Penumbra catheter as expected. According to the MAUDE report, the patient was placed in comfort care and died only two days later.

Unfortunately, these incidents are not isolated. According to the FDA’s recall announcement, there have been over 200 reports associated with the device. These reports include 14 unique Penumbra catheter deaths in addition to a number of other serious injuries and malfunctions. Although the catheter has been recalled, patients and their families may still be struggling with the consequences of severe or life threatening injuries from the Penumbra catheter.