Penumbra Catheter Recall Lawsuit in 2025 | Get the Right Lawyer

Penumbra Jet 7 Catheter Lawsuit Overview

The Penumbra Jet 7 Catheter lawsuit involves claims against Penumbra Inc. for serious injuries and deaths related to their catheter device used in thrombectomy procedures.

Allegations center on design defects that caused the catheter to break or fray during procedures, resulting in patient harm.

The FDA has received numerous adverse event reports, ultimately leading to an urgent recall of the device.

Patients who suffered complications following catheter use are seeking compensation through Penumbra Jet 7 Catheter lawsuits.

Latest Penumbra Jet 7 Catheter Lawsuit Updates

December 15, 2020 – Penumbra recalled its Jet 7 Flex tips catheter following reports of serious injuries and deaths. According to ClassAction Organization, Penumbra’s stock price fell by 7%, from $188.82 per share on December 15, 2020 to $174.98 per share on December 16, 2020, a decline of $13.84 per share. [1]

August 31, 2020 – The FDA limited further use of the medical device with updated labeling, which included a warning against contrast injection through the device.

July 27, 2020 – The FDA prompted Penumbra to issue a notification to healthcare providers with immediate labeling mitigations due to reports of deaths, serious injuries, and malfunctions associated with the use of the device.

February 27, 2020 – The FDA received the Jet 7 Xtra “configuration,” which includes the Jet 7 Reperfusion Catheter and Xtra Delivery Device.

June 16, 2019 – The FDA cleared the Jet 7 Xtra Flex catheter for medical use in stroke patients.

FDA Reports and Statistics

After the clearance of the Jet 7 Flex Tips, the FDA received reports of over 200 medical device reports (MDRs) associated with the Jet 7 Flex tips catheter by healthcare providers with warnings and procedures to mitigate risk, according to the FDA’s recall notification.

On July 27, 2020, Penumbra sent an urgent letter to healthcare providers detailing 14 reported adverse events related to the Jet 7 Flex catheter.

The letter warned providers not to inject contrast media through the Jet 7 Flex Reperfusion Catheter. They should use the system only to treat patients with acute ischemic stroke.

The labeling update also included warnings of problems with the device. Some reports were related to proximal end breakage malfunctions.

By August 31, 2020, the FDA reported further use of the medical device with updated labeling, which included a warning against contrast injection through the device.

According to The Foundation for Financial Journalism, some surgeons have alleged that while they attempted to remove blood clots from patients’ brains, Penumbra’s newest catheter would occasionally break or fray, resulting in precious minutes spent addressing the fracture. [2]

Penumbra Jet 7 Catheter Injuries & Side Effects

The Penumbra catheter is used to restore blood flow by removing clots during thrombectomy procedures in patients suffering from stroke. Serious side effects can occur within 8 hours of symptom onset, according to the U.S. Centers for Disease Control.

Users of the Penumbra Jet 7 Flex catheter have reported serious complications including:

• Vessel Damage: Perforations and ruptures
• Hemorrhage: Severe bleeding in the brain
• Death: Fatal complications
• Stroke Complications: Additional strokes
• Vessel Dissection: Tearing of blood vessel walls
• Fragments in Blood Stream: Broken catheter pieces
• Brain Damage: Permanent neurological impairment
• Additional Surgeries: Procedures required to remove broken catheter pieces

Do You Qualify for a Penumbra Jet 7 Catheter Lawsuit?

You may qualify for a Penumbra Jet 7 Catheter lawsuit if:

• You or a loved one underwent a procedure using a Penumbra Jet 7 Reperfusion Catheter with Xtra Flex technology
• The procedure occurred between June 2019 and December 2020
• You or your loved one experienced serious complications following the procedure
• The complications required additional medical treatment, surgery, or resulted in death
• You can provide medical documentation linking your injuries to the Penumbra device

Evidence Required for a Penumbra Jet 7 Catheter Lawsuit

To pursue a successful claim, you’ll need:

• Medical records documenting the use of Penumbra Jet 7 Catheter
• Documentation of injuries or complications that occurred following the procedure
• Proof of additional medical treatments required due to complications
• Expert medical testimony linking the injury to the device
• Product identification information (if available)

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Damages You Can Recover

Victims can seek compensation for:

• Medical expenses (past and future)
• Lost wages and diminished earning capacity
• Pain and suffering
• Emotional distress
• Loss of enjoyment of life
• Wrongful death damages (for family members of deceased victims)
• Punitive damages (in cases of gross negligence)

Penumbra Jet 7 Catheter Recall Information

December 15, 2020: Penumbra issued a nationwide urgent voluntary medical device recall for certain Jet 7 Reperfusion Catheters over reports of potential injury or death when used for removing blood clots in stroke patients.

This urgent recall was issued after the FDA received at least 200 medical device reports (MDRs) associated with the Jet 7 Flex tips catheter, including deaths, serious injuries, and malfunctions.

The recall specifically affected:

• Penumbra Jet 7 Xtra Flex catheter, originally cleared under K190010
• Penumbra Jet 7 MAX configuration (with Xtra Delivery Device) cleared under K191946 on February 27, 2020

The recall advised healthcare providers to immediately stop using the affected devices and return them to the manufacturer. According to the FDA’s database, approximately 30,000 units were affected by this recall nationwide.

Statute of Limitations for Penumbra Jet 7 Catheter Lawsuits

The statute of limitations for filing a Penumbra Jet 7 Catheter lawsuit varies by state, but typically ranges from 1-3 years from the date of injury or from when you reasonably should have discovered the injury was caused by the device.

Some states follow the “discovery rule,” meaning the limitations period begins when you knew or should have known about your injury and its connection to the device.

Given these time constraints, it’s crucial to contact an attorney as soon as possible if you believe you have a case. The longer you wait, the more challenging it may be to gather evidence and file within the legal deadline.

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FAQs

1. What defects are alleged in the Penumbra Catheter lawsuit?

Alleged defects include catheter breakage, separation, and malfunction during thrombectomy procedures, which can cause severe complications and necessitate additional surgeries. The catheter may fracture or detach inside blood vessels, potentially causing life-threatening complications.

2. What compensation can be sought in a Penumbra Catheter lawsuit?

Victims can seek compensation for medical expenses, lost wages, pain and suffering, emotional damages resulting from the defective product. The specific amount varies based on injury severity and individual circumstances.

3. Is compensation available for those affected by defective Penumbra catheters?

Yes, you may be eligible for compensation for medical expenses and other damages. Consult with a legal professional to discuss your case and determine what compensation you may qualify for under product liability laws.

4. How can I prove my injuries were caused by a defective Penumbra catheter?

Penumbra is actively working with regulatory agencies to investigate the defect and implementing measures to prevent future incidents. Your medical records, operative reports, and expert testimony will be crucial in establishing the connection between the device failure and your injuries.

5. How long does it take to settle a Penumbra catheter lawsuit?

Most medical device lawsuits take 1-3 years to resolve, with more complex cases potentially taking longer. The timeline depends on factors like evidence availability, the number of plaintiffs, and whether the case settles or goes to trial.

6. Have there been any settlements in Penumbra Jet 7 lawsuits?

To date, there have been no large mass tort settlements involving Penumbra Jet 7 catheters and the link to injuries and death. Generally, litigation like this takes many years to resolve, with teams of lawyers examining millions of pages trying to determine exactly what occurred, and how it could have been prevented.

7. What is the litigation process for a Penumbra Jet 7 lawsuit?

Large groups of settlements do not generally occur until a few cases are tried before a jury, and the manufacturer can more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases consolidated for discovery purposes through multidistrict litigation.

8. What should I do if I’ve been injured by a Penumbra catheter?

If you choose to file a potential claim against Penumbra, contact an attorney who specializes in these time-limited cases for a thorough evaluation. Once this time limit passes, you won’t be able to seek potential compensation for injuries or death associated with the Jet 7 Catheter.

Get A Free Penumbra Jet 7 Catheter Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action due to statutes of limitations that vary by state. Many states only allow 2 years from the date of injury to file your claim, so acting promptly is essential.

Our Schmidt & Clark, LLP legal team offers:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case
• Nationwide representation with expertise in medical device litigation

Reference:

1. https://www.classaction.org/media/williams-v-penumbra-inc-et-al.pdf
2. https://ffj-online.org/2020/09/14/penumbra-inc-s-catheter-fail-broken-tips-and-lost-lives/