Penumbra Catheter Recall Lawsuit

Legal Representation for Penumbra Catheter Injuries

Did you or a loved one suffer an injury or illness from a defective Penumbra catheter? Do you want to learn about your legal options for seeking compensation from the manufacturer? If so, contact Mass Tort Alliance immediately for a free case evaluation to determine if you’re eligible to take legal action.

In lawsuits that have been filed, patients claimed that Penumbra JET 7 catheters have a high failure rate due to a defective design. These design flaws have made the device unsafe for patients, resulting in a range of injuries, illnesses, and other medical conditions.

The cost of treatment for the conditions that result from the use of the Penumbra JET7 catheters can upend anyone’s life and put them in debt. While you’re recovering, you should not have to face the responsibility of conducting a legal case. That’s where Mass Tort Alliance comes in.

Our team of professionals can connect you to a law firm that will treat you as a priority and fight hard for the maximum compensation you need to cover your expenses. You should not be forced to pay for anything out-of-pocket when someone else was at fault for your injury. At Mass Tort Alliance, we’ll be ready to help you get the justice and fair compensation you deserve. Contact us today to learn more about how we can help.

Problems with the Penumbra JET 7 Catheter

The Penumbra catheter is a device surgeons use during a thrombectomy on stroke patients. It can remove blood clots from blood vessels in the brain. It’s best for people who aren’t good candidates for a stent retrieval thrombectomy or medication. Although successful in treating individuals with acute ischemic stroke secondary to intracranial large vessel occlusions, there can be harmful side effects.

The manufacturer failed to disclose the dangers of its medical device to doctors and patients who freely used it. The use of the catheter led to countless injuries, illnesses, and deaths. The most common complications associated with the defective catheter are:

  • Ruptured device
  • Exposure to support coils
  • Distal tip fracture
  • Expansion of the device
  • Fraying or detachment of the distal tip

Any of these issues could lead to dangerous medical conditions, including:

  • Coma
  • Hemorrhage
  • Brain damage
  • Anaphylactic reactions to the contrast media
  • Cerebral infarction
  • Damaged blood vessels
  • Ruptured arteries
  • Infections
  • Kidney damage
  • Leaking arteries
  • Blood clots
  • Exposure to radiation
  • Air embolisms
  • Death

If you or a loved one suffered from any of these complications after an operation involving the Penumbra catheter, do not hesitate to contact Mass Tort Alliance to discuss your case.

By definition, medical devices should never make a patient's condition worse. If a Penumbra catheter is responsible for your or a loved one's health issues, an attorney can help you hold its manufacturer accountable. Contact Us

FDA Recall of JET 7 Catheters

The U.S. Food and Drug Administration notified all healthcare providers of an urgent recall of some of Penumbra’s JET7 catheters on December 15, 2020. The manufacturer based its decision to recall the device on multiple reports of severe injury and unexpected death after it was used to remove blood clots in stroke patients.

The devices included in this recall are:

  • JET 7MAX configuration, including the MAX Delivery Device
  • JET 7 Xtra Flex catheter

This recall doesn’t include the JET 7 Reperfusion Catheter with Standard Tip.

The manufacturer performed bench testing on its medical devices and found an issue with the distal tip. The tip is unable to withstand the burst pressures handled by larger catheters during the removal of blood clots.

According to over 200 medical device reports received by the FDA, these catheters malfunctioned during use, causing injuries and fatalities. In particular, one adverse event led to the death of fourteen different patients.

Timeline of the Use of the Penumbra Jet 7 Catheter

June 16, 2019

The FDA approved the Jet 7 Xtra Flex catheter for medical use.

February 27, 2020

The FDA cleared the use of the Jet 7MAX configuration, including the MAX Delivery Device and Jet 7 Xtra Flex catheter

July 27, 2020

The FDA urged Penumbra to notify medical professionals about the potential dangers of the device and instructions on mitigating the risks of injury and death.

August 31, 2020

The FDA allowed continued use of the catheters after the manufacturer provided adequate warning labels.

August 31, 2020 to present

The FDA received new reports about malfunctioning devices and the failure of some doctors to follow the updated instruction labels. They requested the manufacturer to voluntarily recall the Jet 7 Xtra Flex to prevent further injuries to patients.

December 15, 2020

Penumbra issued a voluntary recall of multiple types of catheters.

Recalled Penumbra catheters can pose a health risk to patients who used them. If you or a loved one were seriously hurt after using a Penumbra catheter, can hold its manufacturer accountable for your medical costs and other expenses. Mass Tort Alliance has teams of lawyers across the country who are able to take on your case and stand up for your rights. We Can Help

Pursuing a Product Liability Case

A product liability case is a legal action used to hold manufacturers and other companies liable for providing the public with defective or unsafe products. When you file a lawsuit against Penumbra, you must base your claim on at least one of three defects:

  • Manufacturing Defect – The manufacturer made an error while constructing or assembling the catheter, causing an unreasonable danger to the user.
  • Design Defect – A flaw in the design created an inherently unsafe product that doesn’t meet quality or safety standards.
  • Marketing Defect (Failure to Warn) – The manufacturer failed to provide instructions and warning labels of the risks users could face while using the device.

Penumbra placed profits over patient safety. Instead of initially warning doctors and stroke patients of the harm their catheter models could cause, they decided to hide these risks. It wasn’t until the FDA stepped in and required that they add updated instructions and labeling that they finally included notice of the adverse side effects in their warnings.

Compensation Available In A Penumbra Catheter Lawsuit

If you sustained injuries from one of Penumbra’s catheters and want to seek compensation, you could file a lawsuit. There is a statute of limitations you must comply with if you’re going to sue the manufacturer to recover your losses.

A statute of limitations is a strict timeframe for initiating civil action with the courts. Most states have a deadline of between one and six years after the harm is detected to file a lawsuit. If the deadline passes before you get a chance to sue, you might lose your opportunity to pursue compensation in court.

Injuries resulting from a defective catheter can lead to various economic, emotional, and physical losses. You deserve to pursue compensation for these past and future losses, so you don’t have to pay for anything yourself. These losses might include:

  • Hospital and medical expenses
  • Loss of enjoyment of life
  • Mental anguish
  • Emotional distress
  • Lost wages and future earnings
  • Out-of-pocket costs
  • Future cost of medical care
  • Pain and suffering
  • Disability or disfigurement
  • Loss of consortium

Your attorney will review the details of your case to determine a fair monetary value in your case. The amount of money you receive should sufficiently cover the total losses associated with the injury.

Penumbra Catheter Reports

Out of over 30,000 units of catheters, Penumbra knows of 14 events involving death and 17 events involving injuries due to distal tip damage. This includes damage from a ruptured or expanding device. In total, the manufacturer filed 239 reports associated with the JET 7 Xtra Flex and events leading to malfunctioning, injury, or death.

Why Choose Mass Tort Alliance?

At Mass Tort Alliance, we have extensive experience helping our clients get justice for defective medical device claims like Penumbra catheter injuries. You suffered injuries that never should have happened. The manufacturer placed patients in harm’s way by choosing to hide their knowledge of the product’s dangerous side effects. When you hire us, you can count on our team to provide a range of quality services including:

24/7 Availability

Our call center is open 24 hours a day, seven days a week. If you want to discuss a possible legal case with us, you can count on someone to answer your call.

Free Case Evaluation

We will review your catheter injuries and other related factors for free. After determining your legal options, we can put you in touch with a lawyer who can best meet your needs.

Personalized Service

We provide every person we speak to with the personalized attention they deserve. Everyone has a unique case, and we make sure to approach each one accordingly.

Streamlined Intake

We use advanced systems and cutting-edge technology to gather the necessary information from you, so the intake process is a breeze.

Contact Us

You suffered significant injuries from a defective Penumbra catheter and shouldn’t have to pay out of your own pocket for damages caused by another’s wrongdoing. Don’t face the legal battle alone. You deserve to have a compassionate and aggressive lawyer on your side who will fight with you until the very end. At Mass Tort Alliance, our team is waiting to take your call and get you on the road to recovery. We know how much a traumatic situation like this can disrupt your whole life. You don’t deserve to suffer any further because of the manufacturer’s negligence. When you call Mass Tort Alliance, we will work hard to provide the services you need so you receive top-notch legal representation. There are strict filing deadlines to follow, so don’t wait another minute to contact us. Contact us for a free case evaluation if you sustained injuries from a recalled or defective Penumbra catheter and want to learn more about your legal options for pursuing compensation.