Penumbra JET 7 Xtra Flex Catheter Lawsuits

In December 2020, Penumbra issued a recall for its JET 7 Xtra Flex Catheter because of device malfunctions resulting in serious injury or death. Stroke patients and their loved ones filed JET 7 Xtra Flex Catheter Lawsuits claiming injuries from the device while having a blood clot removed.

Last Modified: May 15, 2024
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Penumbra’s urgent voluntary recall applies to all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex).

Doctors use these devices to remove blood clots and restore blood flow in people who have suffered an acute ischemic stroke. The catheter enters the body through a blood vessel in the leg and travels up through the neck. Once the catheter makes contact with the blood clot causing the stroke, doctors are able to vacuum out the clot and restore blood flow.

Penumbra has reported more than 200 reports of death, injury, malfunction or other adverse events connected to the JET 7 Xtra Flex.

These reports included mentions of device malfunctions, causing serious injuries, including 14 patient deaths caused by distal tip damage and expansion and rupture following contrast injection.

As of June 2024, lawsuits have not been consolidated into a multidistrict litigation, there have been no trials or major settlements. Drugwatch’s legal partners are currently not accepting cases.

Reasons for the Recall

Penumbra issued its urgent voluntary recall because of device malfunctions and breakage that could cause injuries and death.

“Penumbra is recalling the JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death,” according to Penumbra’s Urgent Voluntary Medical Device Recall Notification.

Device failure reports include “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter” according to the U.S. Food and Drug Administration.

The FDA has provided 510(k) premarket notification numbers for the recalled devices.

According to the U.S. Food and Drug Administration, the recalled JET 7 catheters include:
  • The JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
  • The JET 7MAX configuration, which includes the JET 7 Xtra Flex catheter and MAX Delivery Device, cleared under K191946 on February 27, 2020.

FDA Actions and Label Warnings

After the clearance of the JET 7 Xtra Flex, the FDA received reports of device failure. The agency prompted Penumbra to issue a notification to health care providers with warnings and precautions to mitigate risks, according to the FDA’s recall notification.

On July 27, 2020, Penumbra sent a letter to health care providers with warnings.

“JET 7 Xtra Flex may become susceptible to expansion or rupture during contrast injection due to distal tip weakening from manipulation against resistance or use with other manufacturers’ revascularization devices. Distal tip expansion or rupture may cause vessel damage and subsequent patient injury or death,” the letter said.

The letter warned providers not to inject contrast media through the JET 7 Xtra Flex. Instead, they should use the guide catheter to inject contrast.

The labeling update did not stop reports of problems with the device. Some reports were related to providers not following instructions. The FDA requested that Penumbra remove all JET 7 Extra Flex from the market to protect patients.

Injuries Claimed in Lawsuits

Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology are associated with several potential side effects and complications. These include allergic reactions from contrast media, device malfunction, death, air embolism, hemorrhage at access site and infection.

Injuries in lawsuits are linked to device malfunction and breakage.

Injuries included in lawsuits include:
  • Death
  • Hemorrhage
  • Stroke (cerebral infarction)
  • Blood vessel damage

What to Do If You’ve Been Injured

The FDA recommends reporting the injury to MedWatch, the FDA Safety Information and Adverse Event Reporting program. This allows the FDA to identify risks with medical devices.

Make sure you discuss the injuries with your medical provider and understand what your options are for treatment.

Please seek the advice of a medical professional before making health care decisions.