In December 2020, Penumbra issued a voluntary recall for their JET 7 Xtra Flex Catheter. A number of consumers who received the Jet 7 Catheter have suffered serious injury or death due to medical device malfunctions. In particular, many acute ischemic stroke consumers who received the Jet 7 Catheter while having a blood clot removed have suffered serious harm and are likely eligible to claim compensation. The urgent recall applies to all models of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology.
A defective medical device can lead to serious patient injuries and even death. It is essential that manufacturers take great care when designing products to ensure that they are safe, and if complaints are made, it is essential that they act quickly to prevent harm. Unfortunately, this is not always the case.
When lawsuits are brought against medical manufacturers, it helps to enforce high standards and prevents further harm. It is also important that victims achieve justice and are properly compensated for any harm they have suffered. The best way to ensure that you achieve the compensation you deserve is to seek guidance from an experienced catheter injury lawyer.
Contact Holman Schiavone Law, LLC Today To Protect Your Rights!
At Holman Schiavone Law, LLC, our law firm is comprised of highly skilled litigators who are prepared to face even the largest medical device manufacturers and their legal teams. We have a stellar reputation, and insurance defense lawyers know that we are willing to go the distance and take them to court if necessary. This makes them more likely to offer a settlement outside of court to avoid a costly trial.
We pride ourselves on our approach to the attorney-client relationship. We take the time to understand how your injuries have impacted your life and what effect they will have on you and your family in the future. This allows us to fight for fair compensation, which is representative of your suffering and takes into account the ongoing impact on your life.
Our law firm is based in Kansas City. We have an in-depth knowledge of federal and state law in Kansas and Missouri, allowing us to represent victims in all surrounding areas.
We offer a free consultation where we will assess whether we believe you have a case for compensation. Find out what we can do for you by contacting an experienced personal injury lawyer today at 816-320-6108.
What is Penumbra JET 7 Xtra Flex Catheter?
The Jet 7 Catheter is a device that removes blood clots in people who have suffered an acute ischemic stroke. It is a single-use flexible catheter with a large diameter and a guide wire. The catheter attaches to a plastic tube and an aspiration pump which acts like a vacuum.
The catheter is inserted into an artery in the groin which travels to the neck and to the blood clot causing the stroke. Medical professionals will use an x-ray or fluoroscopy to monitor the catheter as it travels through the artery. When the catheter makes contact with the blood clot, it sucks it out and unlocks the blood vessel to restore blood flow. The device can then be guided out of the body.
Penumbra’s first aspiration catheter was approved in 2007. Since then, there have been several configurations of the device. The device was considered to be an innovative solution, and between 2007 and 2018, 80% of suction thrombectomy procedures in the United States used Penumbra catheters.
FDA Actions and Label Warnings of The Jet 7 Xtra Flex Catheter
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.
Penumbra issued a letter that read,
“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 warned healthcare professionals not to inject contrast media through the Jet 7 Catheter and to instead use a guide catheter. However, this warning did not stop reports of problems related to the device.
Recall of Penumbra JET 7 Catheters
In July 2020, the FDA requested that Penumbra issue a Notification to healthcare providers with new label warnings in light of the risks associated with the Jet 7 Xtra Flex Catheter. This voluntary recall from penumbra included all configurations of its Jet 7 Catheters. According to the FDA, the recalled JET 7 catheters include:
- The JET 7 Xtra Flex catheter.
- The JET 7MAX configuration, which includes the JET 7 Xtra Flex catheter and MAX Delivery Device.
The 2020 recall follows over 200 reports to the FDA of medical device failure, resulting in severe injuries such as vessel damage and hemorrhage and 14 deaths. Device failures have included rupture, ballooning, and separation of the catheter’s distal tip.
The JET 7 Xtra Catheter has received the most complaints. It seems that the catheter distal tip is not able to withstand the same burst pressures as the manufacturer’s other large bore aspiration catheters.
Potential Complications of Penumbra Jet 7 Catheters
The FDA received over 200 reports of injury and death related to the Jet 7 Xtra Flex Catheter. According to Penumbra’s Urgent Voluntary Medical Device Recall Notification, the catheter may be susceptible to distal top damage. This, in conjunction with contrast injection or pressurization, could result in vessel damage and patient injury or death.
Device failure reports include expansion, ballooning, breakage, rupture, or complete separation and exposure of internal support coils near the distal tip region, leading to injuries such as:
- Cerebral infarction.
- Vessel damage.
If you have lost a loved one because of a JET 7 Xtra Flex Catheter, then you may be eligible for compensation in a wrongful death lawsuit. Or, if you or a loved one has been seriously injured, then you may be able to claim compensation in a product liability claim.
What to Do If You’ve Been Injured By a JET 7 Catheter
If you have suffered serious injuries from a Penumbra Catheter device, then you should contact Holman Schiavone Law, LLC, as soon as possible. In a free consultation, we will assess your case and determine whether we believe you could have a claim. There are time limits to filing an injury claim, and once a specified amount of time has passed, you will lose your rights to compensation.
To protect your rights, an attorney needs to get to work quickly to protect evidence and secure compensation in your case. Any information you can have prepared, such as medical records, can help your attorney to assess your case.
The FDA also recommends reporting your injury to MedWatch, the FDA Safety Information and Adverse Event Reporting program. This creates important data for the FDA to identify risks with medical devices and helps to prevent future harm.
It is also important that you have a diagnosis from a medical professional regarding your injuries as soon as possible. You must be treated quickly to prevent further harm. You should follow your doctor’s orders and do everything you can to mitigate your injuries.
What Damages Could I Claim in a Penumbra Jet 7 Catheter Lawsuit?
Injuries from Penumbra Catheter devices are often incredibly serious and potentially life-threatening. The effect that this can have on a victim and their families’ lives is immeasurable. A dedicated personal injury lawyer will take the time to understand your situation and will fight for a compensation figure that represents your experiences now and in the future.
Medical Bills and Associated Costs
Medical bills are often the biggest economic cost of a catheter injury. A successful claim should compensate for all medical bills and associated costs such as medication, childcare while you were receiving treatment, transport to and from the hospital, and more.
A skilled personal injury lawyer will also use expert testimony to determine what the ongoing medical expenses will be to ensure that you are compensated for both past and future costs.
Lost Wages and Lost Earning Potential
Acute ischemic stroke patients who received a Jet 7 catheter will probably already have been suffering lost wages. In these cases, it takes a skilled attorney to work out what damages are a result of negligence and which a patient may have still suffered. Any lost wages as a result of negligence should be compensated for, and if the incident affects a patient’s ongoing ability to work, then they should also be compensated for lost earning potential.
Pain and Suffering Damages
Pain and suffering damages compensate victims for their non-economic losses, such as their mental distress, physical pain, and changes in lifestyle. For example, if you are unable to care for your child or participate in hobbies you once enjoyed, then this should be compensated for.
Non-economic damages can be challenging to quantify, and it is important that you have representation from an attorney who takes the time to understand the effect your injuries have had on your life so that you can be properly compensated.
Unfortunately, there have been a number of deaths reported as a result of Jet 7 Xtra Flex Catheter failure. If you have lost a family member because of a medical device error, then you may be able to claim compensation in a wrongful death lawsuit. Damages you may be able to claim, include funeral expenses, loss of income to a family household, and pain and suffering damages.
No amount of money can begin to make up for the loss of a loved one, but you should not have to suffer financially as a result of the negligence of a device manufacturer.
Punitive damages are only awarded in cases that go to trial as they can only be awarded by a judge. They are only awarded if the negligent party act particularly recklessly or intentionally. They give the judge an opportunity to punish the perpetrator or discourage similar actions in the future.
Who is Liable For Penumbra Jet 7 Catheter Failure?
If you or someone you love has suffered an injury from a Penumbra Catheter device, then it is very likely that the device manufacturer, Penumbra, is liable for your damages. The sheer number of complaints suggests that the devices are not as durable as they should be and pose preventable risks.
At Holman Schiavone Law, LLC, we will investigate your case and determine who is liable. We have a wealth of experience navigating product liability claims and have the skills, experience, and resources necessary to hold companies responsible.
What a Penumbra JET 7 Catheter Injury Lawyer Can Do For You
Lawsuits that involve large manufacturing companies are never simple. They require experienced representation who are able to produce substantial evidence and understand how to liaise with large legal teams. They must have a large pool of resources at their disposal and have easy access to expert testimony.
At Holman Schiavone Law, LLC, we know what it takes to face medical device manufacturers. We will level the playing field and take over all correspondence so you can focus on your recovery.
Victims of personal injury who secure representation usually end up with a higher settlement figure than those who don’t, even after their legal fees have been taken into account. These cases are highly complex and difficult to prove, but the sooner you secure representation, the better.
In your free consultation, you will have an opportunity to speak with your attorney and ask any questions that they might have. If they think you have a good case and you are happy with their offer, then you may decide to agree to representation. Once you do, your attorney will get to work quickly to:
- Collect evidence.
- Determine liability.
- File the necessary paperwork.
- Liaise with attorneys involved in your case.
- Work out how much you are owed.
- Build a strong case.
- Represent your case in court if your case goes to trial.
- Give you the best chance of securing compensation.
Contact Holman Schiavone Law LLC For Experienced Representation
At Holman Schiavone Law, LLC, we are dedicated to the rights of individuals. We believe that medical device manufacturers must be held to high standards, and we are prepared to face large legal teams to pursue justice and prevent further harm.
If you or someone you love has suffered an injury because of a Penumbra Catheter device, then you should contact our law firm as soon as possible. We will get to work quickly to ensure you have the best chance at securing compensation.
Speak to one of our personal injury attorneys today for a free consultation at 816-320-6108.
The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. We invite you to contact us and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established.