What's the Problem?
According to the U.S. Food and Drug Administration (FDA) [1], Penumbra's urgent voluntary recall affects:
- Penumbra JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- Penumbra JET 7MAX configuration (with Max Delivery Device) cleared under K191946 on February 27, 2020.
This urgent recall was issued after the FDA received at least 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, blood clots, serious injuries, and malfunctions.
"Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single event," FDA said. "Other MDRs describe severe injury such as vessel damage, hemorrhage, and cerebral infarction."
The Penumbra catheter is used to restore blood flow by removing clots using continuous aspiration in patients suffering from acute ischemic stroke within 8 hours of symptom onset, according to the U.S. Centers for Disease Control (CDC).
Testing by Penumbra has found that the JET catheter is not able to withstand the same burst pressures to failure as Penumbra's other large bore aspiration catheters used to remove blood clots in stroke patients injured.
"Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation exposure, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter," FDA said.
This recall began on December 15, 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 healthcare providers with warnings and precautions to mitigate risks, according to the FDA’s recall notification.
On July 27, 2020, Penumbra sent an urgent letter to healthcare providers with warnings.
“JET 7 Xtra Flex may become susceptible to expansion or rupture during contrast injection due to distal tip damage from manipulation against resistance or use with other manufacturers’ revascularization medical devices. Distal tip weakening 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 technology. 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.
Related Article: Atherectomy Amputation Lawsuit
Can I Sue Penumbra?
Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology are associated with several potential adverse events and complications. These include allergic reactions from contrast media, device malfunction, death, air embolism, hemorrhage at the access site, and infection.
Injuries in lawsuits are linked to device malfunction and breakage.
Serious injuries included in lawsuits include:
- Death
- Hemorrhage
- Stroke (cerebral infarction)
- Blood vessel damage
- Other adverse events
Related Articles:
- Catheter Injury Recall Lawsuit
- ACIST Kodama Catheter Recall Litigation
- Medtronic HawkOne Directional Atherectomy System Suit
See all related defective medical device litigations we've taken on.
What to Do If You’ve Been Injured
If you choose to file a potential claim against Penumbra, contact an attorney right away. There are time limits to file a serious patient injury claim. Once this time limit passes, you won’t be able to seek potential compensation for injuries or death associated with the JET 7 Xtra Flex Catheter.
Gather all medical records and prepare to discuss details with your legal team to see if you qualify to file a lawsuit.
The FDA recommends reporting the injury to MedWatch, the FDA Safety Information and Adverse Event Reporting program. This allows the FDA to identify increased risk with Penumbra 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.
Have There Been Any Settlements?
To date, there have been no large mass torts settlements involving Penumbra Jet 7 Catheter and the link to injuries and death. Generally, however, litigation like this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.
Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation (MDL).
Penumbra Jet 7 Lawsuit Timeline
June 16, 2019: FDA cleared The Jet 7 Xtra Flex catheter for medical use.
February 27, 2020: FDA cleared the Jet 7MAX configuration, which includes the Jet 7 Xtra Flex catheter and MAX Delivery Device.
July 27, 2020: FDA prompted Penumbra to issue a notification to Healthcare Providers with immediate labeling mitigations that included additional warnings, precautions, and instructions to mitigate risks associated with the use of the device.
August 31, 2020: FDA cleared further use of the medical device with updated labeling, which included a warning against contrast injection through the device.
August 31, 2020-present: FDA continues to receive new medical reports detailing Jet 7 Catheter’s failures. In some instances, healthcare providers failed to follow the updated instructions. To protect patients, the FDA asked Penumbra to voluntarily remove the Jet 7 Xtra Flex from the market.
December 15, 2020: Penumbra recalled its Jet 7 Xtra Flex catheter device.
Get a Free Penumbra Catheter Lawsuit Evaluation With Our Lawyers
Our Medical Device Litigation Group is an experienced team of trial lawyers that focus on the representation of plaintiffs in Penumbra Catheter Lawsuits. We are handling individual litigation nationwide and currently accepting new medical device lawsuits in all 50 states.
If you or a loved one was injured, you should contact us immediately. You may be entitled to a settlement by filing a suit and we can help.
