Our Lawyers at Alonso Krangle, LLP are Reviewing Recalled Catheter Lawsuits Related to the Penumbra Jet 7 Xtra Flex Catheter
If you or someone you love suffered injuries because of the Penumbra Jet 7 Xtra Flex Catheter, you might be eligible to collect compensation. Penumbra has recalled this dangerous medical device because it can break and cause serious injuries to stroke patients. Our lawyers are reviewing claims for individual stroke victims who suffered severe injuries from Penumbra Jet 7 catheters.
What is The Penumbra Jet 7 Flex Catheter? What is it Used For?
When someone has a stroke, a blood clot has formed and prevents blood from flowing to the brain. Doctors have to eliminate the clot to restore the flow of blood and oxygen.
The Jet 7 Xtra Flex catheter, made by Penumbra, is a medical device used to remove blood clots from stroke victims. The catheter and a guidewire are inserted into an artery in the patient’s wrist or groin. Using imaging technology and contrast, doctors move the catheter up the body until it reaches the clot in the brain. Then, using suction, the blood clot is removed, and blood flow can resume. This technique is called a mechanical thrombectomy. Doctors use the Penumbra Jet 7 Xtra Flex catheter to perform this procedure when drug intervention does not work or is not appropriate.
Unfortunately, the flex tip (the distal tip) of the Penumbra Jet 7 Xtra Flex catheter can break during the procedure. The result of such breakage can include severe injuries or death to the patient. Reports of injuries because of defective Penumbra Jet 7 Xtra Flex catheters have led Penumbra to recall the dangerous medical devices. Penumbra advised doctors to stop using these catheters immediately.
What is the Problem With Penumbra Jet 7 Xtra Flex Catheters?
Penumbra determined that under pressure, the distal tip of the Jet 7 Xtra Flex catheter could break, balloon, or separate inside patients’ bodies, causing severe injuries. The US Food and Drug Administration (FDA) has received more than 200 adverse medical device reports that make it clear, doctors should not be using this dangerous device to treat patients.
The reports connected with the Jet 7 Xtra Flex Catheter include death, serious injuries, and malfunctions. At least 20 reports describe “unique patient deaths.”
Others reflect serious injuries to patients, including:
- Cerebral infarction
- Vessel damage
These reports are sufficient for Penumbra and the FDA to be concerned about the continued use of the Jet 7 Xtra Flex catheters. Penumbra asked doctors to stop using them immediately and to remove them from their active inventory.
If you or a family member experienced severe complications and injuries after stroke treatment using the recalled Jet 7 Xtra Flex catheter, you might be eligible to file a lawsuit against Penumbra.
The Penumbra Jet 7 Xtra Flex Catheter’s History
In lawsuits against manufacturers of defective or dangerous devices, it sometimes helps to look at the steps that brought the product to where it is today. The FDA regulates drugs and medical devices in the US to ensure they are safe and that any risks are marked on the labels. Here is the story of Penumbra’s Jet 7 Xtra Flex catheter.
- The FDA approved the Penumbra Jet 7 Xtra Flex catheter for use on June 16, 2019, for performing mechanical blood clot removal in certain stroke patients.
- On February 27, 2020, the FDA approved the Jet 7 MAX configuration, including the Jet 7 Xtra Flex Catheter and MAX Delivery Device.
- The FDA took some time after that to analyze the Jet 7 Xtra Flex catheter and felt it needed better labeling. The FDA went back to Penumbra in July 2020 and advised it the labeling had to change or the agency would not continue to approve the device for its intended use. The FDA specifically requested that Penumbra issue a notice to healthcare providers containing “immediate labeling mitigations.”
- On August 31, 2020, the FDA cleared the device for continued use with new labeling. The new labeling included a warning against injecting contrast through the device.
The manufacturer claims that it quickly made the requested changes to the labeling to ensure healthcare providers understood the risks associated with using the catheter to remove blood clots. Penumbra’s revisions included instructions on how to use the catheter safely without harming the patient.
- After receiving reports that the Jet 7 Xtra Flex catheter failed and patients became injured, the FDA eventually asked Penumbra to voluntarily recall the catheters.
- Penumbra recalled its Jet 7 Xtra Flex catheter device in December 2020.
Presently, the FDA continues to receive adverse reports about the Jet 7 Xtra Flex. It is clear the Penumbra Jet 7 Xtra Flex catheter does not function safely, even when instructions are followed properly.
If you suffered injuries because of the Penumbra Jet 7 Xtra Flex catheter, call our office to find out if you can seek compensation for your injuries.
What Should You Do if You Were Injured by the Penumbra Jet 7 Xtra Flex Catheter?
If you or someone you love had a stroke and were seriously injured because of treatment with the Penumbra Jet 7 Xtra Flex catheter, you might be eligible to file a lawsuit. When dangerous medical devices are recalled after people are injured, lawsuits often follow.
You will need to find out if the recalled catheter was used in your procedure. You can usually do this by asking the doctor or surgeon for your records and notes regarding your procedure. If your doctor used a Penumbra Jet 7 Xtra Flex catheter, call our lawyers right away.
We want to hear about your procure and the injuries that resulted to determine if you can file a claim for damages.
In this instance, there is a chance that Penumbra was negligent in the design or manufacturing of the device or in placing the Jet 7 Xtra Flex catheter on the market. Many medical device lawsuits involve questions such as:
- Did the manufacturer provide appropriate warnings of the dangers?
- Was there a safer way to make the device?
- Should the manufacturer have known about the dangers and risks?
- Did they conduct adequate testing?
- Did the negligence cause injuries or death?
- How bad are the injuries?
Call our experienced medical device recall lawyers at Alonso Krangle, LLP. We can investigate your claim, determine how negligence occurred, and get started building your case. Our goal is to ensure you collect the maximum compensation the laws allow.
Is There A Time Limit To File Claims Related to Recalled Catheters?
There are time limits to file all legal claims, including claims associated with recalled medical devices like the Jet 7 Xtra Flex catheter. To ensure there is sufficient time to gather information, collect records, and investigate the viability of your claim, contact our lawyers at Alonso Krangle LLP as soon as possible. We don’t want you to forfeit any of the legal rights you might have to collect damages.
What Is My Case Worth?
There are no guarantees that when you file a lawsuit against the manufacturer of a defective medical device that you will collect compensation. To date, there have been no formal trials or settlements directly related to the recalled Penumbra Jet 7 Xtra Flex catheters.
If you are successful in proving that there was negligence and that you or your loved one suffered serious injuries because of the recalled catheters, compensation could include:
- Economic damages for things like medical expenses, lost wages, lost future income, and other costs associated with treatment, recovery, and/or long-term care.
- Non-economic damages for things like emotional distress, pain, suffering, mental trauma, and anxiety
- In very rare cases, you might receive an award for punitive damages, which are not supposed to compensate the victim but punish the wrong-doer for egregious behavior and prevent others from acting similarly.
At Alonso Krangle, LLP, our lawyers work hard to ensure our clients collect compensation that is fair, just, and accurately reflects the extent of their injuries and losses. Call us to find out how we can help if the Jet 7 Xtra Flex catheter injured you.
Are You Wondering “Can I File a Lawsuit If I Was Injured by a Recalled Catheter?”
Call our lawyers at Alonso Krangle, LLP, to find out.
Our lawyers at Alonso Krangle, LLP have the experience, skills, and resources to ensure that you and your loved ones receive fair compensation when they are injured by a defective, dangerous medical device. The Penumbra Jet 7 Xtra Flex catheter has caused hundreds of injuries, and its recall indicates that they could have been prevented.
If you or your loved one suffered a stroke and was injured during a procedure using the Jet 7 Xtra Flex catheter, call us today at 800-403-6191. Find out if you are eligible to file a lawsuit against Penumbra by speaking to our lawyers at Alonso Krangle, LLP.