Penumbra Jet 7 Catheter Recall

Penumbra catheters are medical devices used to restore blood flow by removing clots in patients experiencing strokes. The FDA announced a Class I recall for Penumbra catheters, indicating that the catheters may pose a risk of serious injury or death for the patient. At least 14 deaths and 239 reports of injury or malfunction associated with Penumbra catheters. Many personal injury lawsuits have been filed by patients who have experienced injuries associated with the Penumbra catheters ballooning, expanding, or breaking.

Sign up for our newsletter to get updates on drugs & medical devices

If you would like to sign up for our newsletter click the button below.

Sign Up For Newsletter

What Is the Penumbra Catheter?

The Penumbra catheters are intended for use in patients who experienced an acute ischemic stroke in order to restore normal blood flow. They also have catheters that are designed to navigate through vessels in order to extract a blood clot efficiently.

Who Is Penumbra?

Penumbra Inc. is a medical device company that is focused on designing, developing, and manufacturing products for neuro and vascular markets. Its major products include neurovascular access systems, revascularization devices, and microcatheters. 

Penumbra sells its products to specialist physicians, hospitals, and clinics through direct sales organizations. It also distributes its products through distributors globally and has operations in the U.S., Brazil, Germany, Australia, Canada, France, and the UK. Their headquarters are located in California. 

What Is a Nuero Access Catheter?

A neurovascular catheter is used for brain navigation to support specifically blood clot irrigation for ischemic stroke patients. Different types of microcatheters can be designed for neurovascular applications, depending on the condition that is being treated.

Common applications for neurovascular microcatheter design projects include: 

  • Stent and graft delivery devices, including to the carotid artery
  • Aneurysm coiling systems
  • Embolization catheters
  • Occlusion catheters and balloon catheters
  • Catheters for thrombolytic treatments

When Was the Penumbra Catheter Developed?

Penumbra introduced its first neuro access device in 2007 and has since expanded its intracranial access products since then. These devices are designed to address additional clinical challenges specific to the neurovasculature. 

What Is an Ischemic Stroke?

An ischemic stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This loss of oxygen and blood leads the brain cells to begin decaying and they can begin to die within minutes. 

The catheters aim to prevent extreme brain damage by creating a channel of blood flow back to the brain. 

What Causes an Ischemic Stroke?

An ischemic stroke is the most common type of stroke. It happens when the brain’s blood vessels become narrowed or blocked, causing severely reduced blood flow. This is caused by fatty deposits that build up within the blood vessels or by blood clots or other debris that travels through the bloodstream and then lodge into the blood vessels in the brain. 

What Are the Risk Factors of a Stroke?

Some lifestyle risk factors that can increase the risk of stroke include: 

  • Being overweight or obese
  • Physical inactivity
  • Heavy or binge drinking
  • Use of illegal drugs such as cocaine and methamphetamine

Additionally, some medical factors that can increase the risk of stroke are: 

  • High blood pressure
  • Cigarette smoking or secondhand smoke exposure
  • High cholesterol 
  • Diabetes
  • Obstructive sleep apnea
  • Cardiovascular diseases
  • Family history of strokes
  • Covid-19 infection

What Are the Symptoms of a Stroke?

A stroke is considered a medical emergency, so if you or someone you know begin to exhibit any of these symptoms, it’s important to seek medical attention as soon as possible.

Some signs and symptoms of a stroke include: 

  • Headache accompanied by vomiting, dizziness, or altered consciousness
  • Trouble walking
  • Problems seeing in one or both eyes
  • Paralysis or numbness of the face, arm, or leg
  • Trouble speaking and understanding others

What Complications Can a Stroke Cause?

A stroke can cause temporary or permanent disabilities, depending on how long the brain lacks blood flow. Some complications may include:

  • Paralysis or loss of muscle movement
  • Difficulty talking or swallowing
  • Memory loss or thinking difficulties 
  • Emotional problems
  • Pain
  • Changes in behavior and self-care ability

How Can a Stroke Be Prevented?

Many stroke prevention strategies are the same as strategies to prevent heart disease and include: 

  • Controlling high blood pressure
  • Lowering the amount of cholesterol and saturated fat in your diet
  • Quitting tobacco
  • Managing diabetes
  • Maintaining a healthy weight
  • Eating a diet rich in fruits and vegetables
  • Exercising regularly
  • Drinking alcohol in moderation
  • Treating obstructive sleep apnea
  • Avoiding illegal drugs

What Is a Blood Clot?

Blood clots form in response to a cut or other injury and they typically stop the bleeding by plugging the injured blood vessel. Blood clots help the body heal. 

However, some blood clots can form inside the veins when no injury occurs and they do not dissolve naturally. Instead, these blood clots may require medical attention, especially if they are in the lungs, legs, or brain. Many conditions can cause this type of blood clot. 

What Causes a Blood Clot?

Arteries contain what are called waxy cholesterol plaques. If the plaque breaks open, that’s when the clotting process starts. That’s usually when the body is trying to stop an injury from bleeding. 

Blood clots can also form when the blood isn’t flowing throughout the body properly. If the blood pools in the blood vessels or heart, the platelets can start sticking together. This slow-moving blood that sticks together can lead to blood clots. 

Who Is More at Risk of Blood Clots?

It’s estimated that people who experience severe COVID-19 symptoms have an increased risk of developing blood clots. Other risk factors include: 

  • Age (65 and older)
  • Pregnancy
  • Obesity
  • Cancer
  • Taking birth control pills
  • Having hormone therapy
  • Smoking

What Are the Symptoms of a Blood Clot?

There are different symptoms that are indicative of blood clots forming and where they might be forming. Symptoms that show a blood clot forming in the arms or legs include: 

  • Swelling
  • Change in color
  • Pain
  • Warm skin
  • Trouble breathing
  • Lower leg cramps
  • Pitting edema
  • Swollen, painful veins

Symptoms of heart blood clots: 

  • Severe pain in chest and arm
  • Sweating
  • Trouble breathing

 Symptoms of lung blood clots: 

  • Shortness of breath or trouble breathing
  • Pain in chest
  • Coughing 
  • Sweating
  • Dizziness

Symptoms of a brain blood clot: 

  • Problems with vision or speech
  • Seizure
  • Weakness

Symptoms of a stomach blood clot”

  • Nausea or vomiting
  • Severe stomach pain, especially after meals
  • Diarrhea
  • Blood stool
  • Bloating

Symptoms of a kidney blood clot: 

  • Pain in the stomach, legs, or thighs
  • Blood in urine
  • Fever
  • Nausea or vomiting
  • High blood pressure
  • Leg swelling
  • Trouble breathing

What Complications Can a Blood Clot Cause?

Complications of blood clots can include heart attack and stroke. Other potential complications include: 

  • Pulmonary embolism
  • Kidney failure
  • Deep vein thrombosis
  • Pregnancy complications

How Can Blood Clots Be Prevented?

Blood clots can be treated with blood thinning medications, but it is better to take steps to prevent blood clots from forming. Some steps that can prevent the formation of blood clots are: 

  • Losing weight
  • Quitting smoking
  • Telling your doctor about any family history of blood clotting

Why Were Penumbra Catheters Recalled?

On December 17, 2020, Penumbra recalled one of their catheters – Penumbra JET 7 Xtra Flex – because the catheter was susceptible to tip damage during use. This catheter was associated with deaths, serious injuries, and malfunctions found in over 200 medical device reports. 

What Is a Brain Hemorrhage?

A brain hemorrhage, also known as a brain bleed, is a type of stroke. They occur when an artery in the brain bursts, resulting in the bleeding. A brain bleed that damages surrounding tissue can lead to serious brain damage and, in worse cases, death

What Are the Symptoms of a Brain Hemorrhage? 

Brain hemorrhages can be deadly, so if you’re experiencing these symptoms, call your doctor or 911 immediately. Brain bleed symptoms may include: 

  • Sudden or severe headache
  • Weakness, tingling, or numbness in the arms or legs
  • Nausea or vomiting
  • Changes in vision
  • Changes in balance
  • Difficulty speaking or understanding speech
  • Difficulty using fine motor skills
  • Seizures
  • Loss of consciousness

What Is a Cerebral Infarction?

A cerebral infarction, also called ischemic stroke, occurs as a result of disrupted blood flow to the brain due to problems with the blood vessels that supply it. A lack of blood supply to the brain cells deprives them of oxygen and nutrients, which can lead to parts of the brain dying. 

What Are the Symptoms of Cerebral Infarction?

Signs of cerebral infarction in both men and women include: 

  • Numbness
  • Confusion
  • Trouble seeing
  • Trouble walking
  • Severe headache

What Is a Coma?

A coma is classified as a state of prolonged loss of consciousness. It is a severe medical emergency and quick action is needed to preserve the life and brain function of the patient. Comas can be caused by underlying illnesses, head injuries, strokes, or drug and alcohol intoxication. 

What Are the Symptoms of a Coma?

The symptoms of a coma commonly include: 

  • Closed eyes
  • Depressed brainstem reflexes
  • No responses of limbs except for reflect movements
  • No response to painful stimuli except for reflex movements
  • Irregular breathing

What Are the FDA’s Warnings About Penumbra Catheters?

The FDA issued a Class I recall, the most serious type of recall the FDA can issue, for Penumbra’s Jet 7 Xtra Flex catheter. Class I recall indicates that the use of this product can cause serious injuries and even death.

Are Penumbra Catheters Still Being Used?

Even though Penumbra’s Jet 7 Xtra Flex catheter was recalled, they’re still producing and selling other catheters they create. They are performing many clinical trials to ensure the effectiveness of their newer designs. 

Why Are There Penumbra Catheter Lawsuits?

It’s reported that many lawsuits claim that Penumbra catheters are defectively designed due to the extremely high failure rate. These failures have resulted in severe consequences for patients, with many experiencing deadly side effects. The malfunctions of Penumbra catheters are too frequent, indicating that the design isn’t effective for its purpose. 

Why Are Plaintiffs Filing Penumbra Catheter Lawsuits?

Plaintiffs are suing Penumbra because the catheter malfunctions and breakage caused their injuries or, in worse cases, their loved one’s death. In addition to death, injuries reported with Penumbra’s catheters include blood vessel damage, hemorrhage, and cerebral infarction. 

Are There Penumbra Catheter Lawsuit Settlements?

As of March 2021, there have been no mass settlements involving Penumbra and their catheters. Any settlements made by Penumbra have been through personal lawsuits and were not recorded. Large groups of settlements can take years to come around. 

Are There Any Active Penumbra Catheter Lawsuits?

Many large lawsuits against Penumbra for the defective catheters are still pending litigation. The FDA is still actively collecting information on Penumbra’s catheters.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 


  • Blood clot symptoms: How to tell if you have one. (2016, March 2). WebMD.
  • Blood clots. (2023, July 19). Mayo Clinic.
  • Brain hemorrhage symptoms & Treatment | Aurora Health Care. (n.d.). Aurora Health Care.
  • Center for Devices and Radiological Health. (2021). Penumbra’s recall of the JET 7 reperfusion catheter due to distal tip damage. U.S. Food And Drug Administration.,%2C%20serious%20injuries%2C%20and%20malfunctions.
  • Coma – Symptoms and causes – Mayo Clinic. (2022, December 14). Mayo Clinic.
  • Consumer Notice. (2021, October 18). Penumbra Jet 7 Xtra Flex Catheter Lawsuits | Status of litigation. Consumer Notice, LLC.,damage%2C%20hemorrhage%20and%20cerebral%20infarction.
  • Ellis, M. E. (2017, September 2). Risk Factors and Complications from Blood Clots. Healthline.
  • Hoffman, M., MD. (2011, January 26). Blood clots. WebMD.
  • Neuro Access Catheters | Penumbra Inc. (n.d.). Penumbra, Inc.,challenges%20specific%20to%20the%20neurovasculature.
  • Neurovascular Microcatheter Design Overview | Arrotek. (n.d.).
  • (2019, February 26). Cerebral infarction.,the%20brain%20to%20die%20off.
  • Penumbra Inc Company Profile – Penumbra Inc Overview. (n.d.). GlobalData.,for%20neuro%20and%20vascular%20markets.
  • Penumbra Jet Reperfusion Catheters | Penumbra Inc. (n.d.). Penumbra, Inc.,Penumbra%20ENGINE%C2%AE%20Aspiration%20Source.
  • Professional, C. C. M. (n.d.). Blood clots. Cleveland Clinic.
  • Stroke – Symptoms and causes – Mayo Clinic. (2023, July 8). Mayo Clinic.,and%20prompt%20treatment%20is%20crucial.
  • Stroke signs and symptoms | (2022, May 4). Centers for Disease Control and Prevention.,headache%20with%20no%20known%20cause.
  • Taylor, N. P. (2022, August 26). Penumbra’s catheters achieve first-pass revascularization in 68.9% of stroke patients. MedTech Dive.