Rosenbaum & Rosenbaum, P.C. | December 17, 2020 | Defective Medical Devices
Have you or a member of your family been injured and/or passed away as a result of a malfunctioning Penumbra Jet 7 Xtra Flex?
Many people in New York and across the nation utilize this catheter have received the news of its recall and have experienced the devastating dangers, as well. You are not alone, and we are here to help.
You may have the right to file a mass tort injury lawsuit and recover compensation for you or your family members medical bills, lost wages, pain and suffering, and/or wrongful death, too. The experienced NYC Penumbra Jet 7 Xtra Flex injury lawyers at Rosenbaum & Rosenbaum, P.C. can help you fight to maximize your financial recovery. Give our New York City law office a call to discuss your legal options today. There’s absolutely no charge for your initial case evaluation.
Penumbra Jet 7 Xtra Flex: What Is It Used For?
The Penumbra Jet 7 Xtra Flex is a catheter used to remove blood clots from the brain in thrombectomy procedures. The Penumbra JET 7 Xtra Flex catheter and Penumbra JET 7MAX configuration are medical devices designed to restore blood flow by removing blood clots using continuous aspiration in patients experiencing an acute ischemic stroke within eight hours of symptom onset. It is specifically used in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Penumbra Recalls the JET 7 Xtra Flex catheter and the JET 7MAX configuration
It has recently been reported that the distal tip of the Jet 7 Xtra Flex catheter can expand and fracture during thrombectomy procedures, causing serious injuries and even death. This expansion and fracture has led to brain bleeds in patients who were originally only dealing with blood clots. Distal tip damage with pressurization or contrast injection could result in potential vessel damage and patient injury or death.
Devices affected by the FDA recall 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.
The FDA reports that since the Penumbra Jet 7 Xtra Flex catheter was introduced to the market, the FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. These MDRs describe 14 unique patient deaths, as well as serious patient injury such as vessel damage, hemorrhage, and cerebral infarction.
Device failure modes reported in the MDRs 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. It was established through testing that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as intended and as other large bore aspiration catheters used to remove thrombus in acute ischemic stroke patients, resulting in this distal tip damage.
As a result of numerous medical device reports received, the FDA had previously prompted the manufacturer to issue a Notification to Healthcare Providers on July 27, 2020, with immediate labeling mitigations that included additional warnings, precautions, and instructions to mitigate risks associated with use of the device by health care providers.
Penumbra warned healthcare providers that the distal tip defect could cause vessel damage and other injuries, including death. On December 15, 2020, Penumbra finally issued an urgent voluntary recall all units of the Jet 7 Xtra Flex catheter and its Jet 7MAX delivery device due to the now 200 plus reports submitted to the FDA.
Do I have a Penumbra Jet 7 Xtra Flex Injury Lawsuit?
The only way to know if you have a legitimate legal claim against Penumbra is by discussing the details of your case with an experienced mass tort injury lawyer in New York City. You may want to really consider scheduling a free consultation with Rosenbaum & Rosenbaum, P.C. if:
- You used the Penumbra Jet 7 Xtra Flex and were injured as a result; or
- Your family member used the Penumbra Jet 7 Xtra Flex resulting in death.
The fact that you know that you or your family member have suffered a serious injury and/or death as a result of a malfunctioning medical device can be traumatic to the individual and the family. Using such a defective device could lead to significant issues down the line as a result of your injuries, leaving you responsible for medical bills, pain and suffering, lost wages, which could severely impact you financially.
There’s no risk in discussing your case and learning about your legal options. Your first case evaluation with our NYC personal injury attorneys is 100% free.
How much is my Penumbra Jet 7 Xtra Flex Injury case worth?
Every case is different. The value of each individual case will ultimately depend on several factors, including:
- You or your family member’s present and future medical expenses
- The severity of injury/ultimate fatality
- You or your family member’s prognosis and what the road to recovery looks like
- The emotional and psychological impact your injury and/or fatality has had on you or your family
Generally speaking, plaintiffs in Penumbra Jet 7 Xtra injury lawsuits will be entitled to recover both economic (financial) and non-economic (intangible) damages. This can include the cost of medical care, lost income and wages, emotional distress, mental anguish, and pain and suffering.
If the Penumbra Jet 7 Xtra causes serious injury and is ultimately fatal, the victim’s surviving family members can potentially be awarded compensation for their costs and suffering through a wrongful death action.
Rosenbaum & Rosenbaum, P.C. can help you navigate this difficult time. Give our law office a call to discuss your rights today.
Defective Medical Devices and New York Product Liability Laws
Even though medical devices like the Penumbra Jet 7 Xtra have to undergo extensive testing to get the FDA’s seal of approval, dangerous and defective medical devices can still find their way into the healthcare market and used by healthcare professionals. Unfortunately, the agency can’t be expected to keep tabs on everything and ensure that all products are safe – especially after they’ve been approved and released onto the market.
In order to compensate for this, states like New York have passed product liability laws to ensure that companies have an incentive to make sure that the products they sell are safe.
Under New York states’ product liability laws, medical device companies can be strictly liable if the devices they design, manufacture, or market are defective and cause harm.
Strict liability means that injured Penumbra Jet 7 Xtra users don’t have to prove negligence. Financial and legal responsibility attaches, regardless of how much care the company used in creating or selling the drug.
Keep in mind that New York limits the amount of time a plaintiff can file a product liability lawsuit against a medical device company. Typically, the statute of limitations is three years from the date of injury (or discovering that injury).
Schedule a Free Consultation to discuss your Penumbra Jet 7 Xtra Flex Injury Lawsuit
Have you or a family member suffered a serious injury and/or fatality while using the Penumbra Jet 7 Xtra? If so, you may have the right to file a lawsuit against Penumbra, the company that manufactured medical device. The NYC mass tort injury lawyers at Rosenbaum & Rosenbaum, P.C. can help you navigate the process and work to maximize your financial recovery.
We offer a free consultation, so don’t delay in reaching out to our law firm to schedule yours today.