Penumbra JET 7 Catheter RecallLawsuit Filed on Behalf of Injured Patients

Penumbra JET 7 Catheter Recall

What is the Penumbra JET 7 Catheter?

Penumbra’s reperfusion catheter is used by many surgeons in thrombectomy procedures when removing blood clots from the veins and arteries of their patients. If you have suffered an injury due to this device, you should contact an experienced JET 7 catheter lawyer immediately.

 

What is its use?

As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are medical devices intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or those who fail IV t-PA therapy.

 

Is it safe?

In several reports regarding the device, arterial ruptures led to patient deaths. In some of these cases, the rupture occurred in the internal carotid artery, which supplies blood to the brain and eyes. Furthermore, certain reported ruptures were associated with damage to the distal tip.

Gabriel Grego, the managing partner at Quintessential Capital Management, published a short thesis calling the Penumbra Jet 7 “unsafe and unmarketable.”

 

 

Penumbra JET 7 Catheter Risks and Injuries

The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Of the MDRs, twenty of them describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. Other MDRs describe serious patient injuries 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.

Additionally, Bench testing performed by the manufacturer, where the catheter distal tip is plugged and pressurized to failure, demonstrates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters.

 

 

Was the Penumbra JET Catheter Recalled?

The U.S. Food and Drug Administration (FDA) has alerted that Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of an unexpected death or serious injury while used for removing clots in stroke patients.

 

Affected Devices

The devices affected by the recall include:

• The JET 7 Xtra Flex catheter, which was 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.

*Note – The recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.

 

FDA Recommendations

The FDA recommends users to follow all instructions provided in Penumbra’s Urgent Voluntary Medical Device Recall Notification:

• Do not use the JET 7 Xtra Flex catheter
• Remove and quarantine all unused affected products in your inventory.
• Return the affected products to Penumbra in accordance with Penumbra’s instructions.
• Complete Penumbra’s product identification/return form.
• Contact Penumbra Customer Service (order@penumbrainc.com or 1-888-272-4606)

Lastly, you should report any adverse events or suspected events experienced with the JET 7 Xtra Flex through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

 

 

What to Do if You Suffer a Penumbra Catheter Injury

If you or a loved one has suffered a Penumbra catheter injury; reporting your injury is the first step in your road to recovery. Here’s how to do so:

Report Injuries to the FDA

Voluntary reports can be submitted through MedWatch. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) Regulations. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

When possible, reports should include the following information:

• Anatomical location, vessel size, time from symptom onset, and concomitant treatments of the vessel occlusion.
• Vessel anatomical characteristics (tortuosity).
• Whether the adverse event occurred intra-procedurally or post-procedurally.
• A complete description of the adverse event and patient outcome, if available.
• The device model names and numbers.
• Any ancillary devices used during the procedure, such as the specific trade name and size of the microcatheter, intermediate catheter, guide catheter, guidewire, and stent-retriever, if applicable.
• Any ancillary fluids or drugs used during the procedure, such as contrast agents and saline flushes, if applicable, and the delivery device used.
• A unique device identifier (UDI)

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

 

 

Filing a Penumbra JET 7 Catheter Lawsuit

The civil litigation process requires extreme attention to detail and can be overwhelming for someone who does not possess extensive legal knowledge. A Penumbra JET 7 catheter lawyer will need to be able to prove the liability of another party for any injuries that you have suffered. Additionally, you will be obligated to show proof of mitigation. Thus, meaning that you have made a concerted effort to treat your injuries. It is imperative to file your claim as soon as possible. If you wait too long, the statute of limitations may expire, and your claim will become void.             

 

 

Hiring a Penumbra JET 7 Catheter Lawyer

Hiring a Penumbra JET 7 catheter Lawyer is a strenuous decision and takes some diligent research. An experienced personal injury attorney can help you in the process of gathering evidence and assessing damages. Also, they will be able to guide you along the legal process by making sure that you receive the maximum amount of compensation for damages that you have suffered. Talk to a professional at TorHoerman Law today to see if you qualify for a Penumbra JET 7 catheter lawsuit.

 

 

TorHoerman Law – Your JET 7 Catheter Injury Law Firm

Our team of expert personal injury lawyers specializes in JET 7 catheter lawsuits. At TorHoerman Law, we have won more than $4 billion in verdicts and negotiated settlements for our clients. We operate on a contingency fee basis. Thus, you do not owe us any payment until you have been compensated for your injury. If you or a loved one have suffered an injury due to this defective product, you may be entitled to financial compensation. Contact a JET 7 catheter lawyer at TorHoerman Law today to discuss your legal options.