The Penumbra Catheter lawsuit claims the Penumbra Jet 7 catheters are defectively designed and fail at an extremely high rate, resulting in severe injury or death.
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What We Know About the Penumbra Jet 7 Catheter Lawsuits
The Penumbra Jet 7 Catheter is a medical device used during surgery to remove blood clots, via suction, from vessels inside the brain of stroke patients. This device is used when the patient does not qualify for medication or stent retrieval thrombectomy, or in cases where these first-in-line interventions have not succeeded.
Unfortunately, the distal tip of the Penumbra Jet 7 Xtra Flex catheter can expand or fracture during the thrombectomy procedure. This can cause complications that result in serious patient injury and/or death. Numerous medical providers have reported a Jet 7 Catheter rupturing inside a blood vessel, causing catastrophic bleeds and death.
On December 15, 2020, the U.S. Food and Drug Administration (FDA) issued a warning letter regarding the urgent recall of the Jet7 Xtra Flex and Jet 7 MAX configuration devices, due to hundreds of recorded instances of these devices failing or causing injury. The FDA’s notice highlights the risk of “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.”
The Key Legal Issue
Penumbra introduced the Jet 7 Xtra Flex catheter in July 2019, but it was not until July 2020 that the manufacturer warned healthcare providers about the distal tip defect and the risk of vessel damage, other injuries, and death.
The FDA’s warning applies to the following Penumbra devices:
- Jet 7 Xtra Flex catheter; and
- Jet 7MAX configuration, which includes the Jet 7 Xtra Flex catheter and MAX Delivery Device.
In its warning letter, the FDA urged healthcare providers to stop using these devices, which had resulted in a minimum of 200 episodes of injury, death, malfunction, or other adverse events.
Penumbra Jet 7 Catheter Injuries & Side Effects
The FDA has received over 200 medical device reports (MDRs) connected with the Jet 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of the reports describe 14 unique patient deaths. Other medical reports detail various forms of serious patient injury, including:
- Vessel damage
- Cerebral infarction
Penumbra Jet 7 Catheter Lawsuit Settlement Amounts
As of March 2021, 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 (known as an MDL).
Timeline of Events Pertinent to Penumbra Jet 7 Catheter Lawsuits
- June 16, 2019: The FDA cleared The Jet 7 Xtra Flex catheter for medical use.
- February 27, 2020: The FDA cleared the Jet 7MAX configuration, which includes the Jet 7 Xtra Flex catheter and MAX Delivery Device.
- July 27, 2020: The 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: The 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: The 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.
How Liability Law Applies to Medical Device Manufacturers
Under most state laws, a patient injured through the use of a defective medical device can bring a lawsuit based on the following legal theories:
- Design Defect: When a medical device is manufactured per design specifications, but the design itself renders the device ineffective or unsafe;
- Manufacturing Defect: When a medical device is safely designed, but retained some defect through the manufacturing process, rendering it dangerous or unsafe; and/or
- Failure to Warn: When the medical device manufacturer fails to warn the public of risks or to provide adequate instructions about use of the device, thereby rendering it unsafe or dangerous.
The state in which you reside enforces a statute of limitations that restricts the amount of time you have to file a lawsuit against a medical device manufacturer. A member of our legal team can inform you of your state’s laws.
Penumbra Jet 7 Catheter Lawsuit News
FDA: Penumbra JET 7 Clot Retrievers Recalled Following Deaths, Injuries
Penumbra is urgently recalling its JET 7 reperfusion catheter with Xtra Flex Technology, used for thrombus aspiration in the setting of acute ischemic stroke, because of its susceptibility to distal tip damage during use. The recall follows a series of deaths and serious injuries due to device malfunction. Reported in TCTMD
Penumbra recalls Jet 7 catheters with Xtra Flex technology
The US Food and Drug Administration (FDA) announced the urgent voluntary recall of Penumbra’s JET 7 catheters with Xtra Flex technology (JET 7 Xtra Flex) due to increased risk of mortality and serious injury. Penumbra initiated the recall on 15 December 2020. Reported in NeuroNews
FDA and Scientific Studies Regarding Penumbra Jet 7 Catheter
Penumbra and its ‘Killer Catheter’: A tale of corporate greed and seemingly blatant disregard for patients’ lives
On November 10, 2020, Quintessential Capital Management published a research report in which authors suggest that Penumbra may have misled doctors and investors in critical aspects of communication. Reported in Quintessential Capital Management PowerPoint Presentation
Is Penumbra’s core scientific research authored by a fake person?: The incredible story of Penumbra’s Dr. Antik Bose
On December 8, 2020, Quintessential Capital Management published a follow-up research report in which the authors allege that some of Penumbra’s scientific research appears to have been incorrectly credited or perhaps written by a fake individual. Reported in Quintessential Capital Management Website