Olympus ViziShot 2 FLEX Biopsy Needle Injury & Wrongful Death Lawsuit Lawyers

Over 103,000 Defective Lung Biopsy Devices Pulled From Market Following Reports of Airway Injuries, Component Ejection, and Fatal Complications

On September 25, 2025, the U.S. Food and Drug Administration (FDA) issued a Class I recall, its most serious warning level, for the Olympus ViziShot 2 FLEX 19G biopsy needle. This medical device, commonly used in ultrasound-guided lung biopsies and cancer staging, has been linked to 14 injuries and one death due to serious device malfunctions.

The FDA’s alert has broad implications for patient safety and product liability law. Over 103,000 units have been affected, and Olympus has issued urgent removal notices to healthcare providers. Patients who underwent a procedure using the ViziShot 2 FLEX may now be at risk of severe internal complications due to loose or broken device components that cannot always be detected on X-rays.

What Is the ViziShot 2 FLEX (19G) Biopsy Needle?

The ViziShot 2 FLEX (19G) is a fine-needle aspiration device used in endobronchial ultrasound (EBUS) procedures. These procedures allow doctors to collect tissue samples from the lungs and surrounding lymph nodes to diagnose lung diseases, including cancer. Physicians rely on the device to access hard-to-reach areas with precision.

Olympus markets the device as offering “flexibility and access to the most challenging locations.” However, recent findings indicate that design flaws may lead to serious injuries, particularly when the tip of the device deforms or the hypotube ejects components into the airway.

FDA Class I Recall: What It Means

The FDA’s Class I recall designation is reserved for products that pose a reasonable likelihood of causing serious injury or death. In this case, Olympus and the FDA acknowledged that the biopsy needle can:

• Eject plastic or metal components into the tracheobronchial tree (airways)
• Cause mucosal injury, bleeding, or infection
• Require emergency removal procedures
• Result in irreversible airway damage or death

The recall applies to devices manufactured before May 12, 2025, and affects a wide range of lot numbers. Olympus began notifying hospitals and clinics in August 2025 with an Urgent Medical Device Removal letter.

How the Device Malfunctions During Use

The defective ViziShot 2 FLEX biopsy needles may have a deformed a-traumatic tip—a critical part of the device that guides it through delicate airway tissues. When the tip is compromised, it can cause:

• Component ejection: Internal parts can dislodge and become lodged in the airway
• Excessive resistance: Physicians may encounter abnormal friction during insertion
• Detached parts: These can break off, entering the lungs undetected

What’s more troubling is that some components are not radiopaque—meaning they cannot be seen on X-rays. As a result, physicians may be unaware that fragments are still inside a patient’s airway after the procedure, increasing the risk of infection, bleeding, or the need for surgical removal.

Injury Reports and Fatal Case Raise Alarms

The FDA has documented 14 injuries and one patient death linked to this device. While details about the fatal case remain limited, the mechanism is consistent with airway compromise from foreign material introduced during a biopsy. This underscores the life-threatening nature of the defect.

Common complications include:

• Mucosal tearing or bleeding
• Lodged components in the bronchial tubes
• Foreign body aspiration
• Airway inflammation
• Infection requiring hospitalization
• Delayed diagnosis or misdiagnosis of cancer due to interrupted procedures

Patients who underwent EBUS with the affected device may not be aware they were exposed to risk—especially if post-procedural symptoms were mild or delayed.

Olympus’ Response and Ongoing Device Concerns

In response to the recall, Olympus began removing specific ViziShot 2 FLEX 19G needles from the market and issued a customer safety notice on September 19, 2025. The company warned physicians:

“For patients with abnormal symptoms or image findings post-procedure, the potential for unanticipated retained device components should be assessed. It is notable that some of these components are not radiopaque.”

The company also reinforced existing precautions, advising physicians not to forcibly push the needle slider if excessive resistance is felt during the procedure.

This is not Olympus’ first encounter with safety concerns. In 2023, the company received multiple FDA warning lettersrelated to deficiencies in its endoscope manufacturing and sterilization protocols. The current recall further undermines confidence in Olympus’ quality control practices.

Who Is at Risk and What Should Patients Do?

Patients who underwent lung biopsies or EBUS procedures between 2023 and 2025 may have been treated with one of the affected devices. The recall affects over 103,000 units distributed throughout the United States.

If you experience the following symptoms after a lung biopsy, it may indicate a retained component or injury caused by a defective needle:

• Persistent cough
• Difficulty breathing
• Chest pain
• Blood in sputum
• Fever or signs of infection
• Abnormal imaging results after the biopsy

In these cases, physicians should assess for foreign body retention, even if prior imaging was negative.

Legal Liability for Olympus and Patient Rights

When medical devices malfunction and harm patients, manufacturers can be held legally responsible under product liability law. In this case, Olympus may face liability for:

• Design defects resulting in needle deformation
• Manufacturing defects in specific lots
• Failure to warn about risks before injuries occurred
• Inadequate post-market surveillance and delayed recall action

Patients may be entitled to financial compensation for the harm caused, including:

• Medical bills for hospital stays, imaging, or corrective surgery
• Lost wages due to extended recovery or disability
• Pain and suffering
• Wrongful death claims in fatal cases
• Long-term respiratory therapy or rehabilitation

The legal process may also force Olympus to answer critical questions about when it became aware of the defect and whether earlier action could have prevented patient injuries.

What You Should Know If You Were Injured by a Recalled Olympus Device

If you or a loved one was injured during or after a lung biopsy procedure, and your medical team used the Olympus ViziShot 2 FLEX 19G, you may qualify for legal action. Even if your injury wasn’t immediately diagnosed, complications from retained components can appear later—especially if they were not visible on X-ray.

Parker Waichman LLP is actively investigating device-related lung injury cases and has a long record of holding medical device manufacturers accountable for preventable harm.

Olympus ViziShot Biopsy Needle Lawsuit FAQs

What is being recalled and why?
The FDA has issued a Class I recall for the Olympus ViziShot 2 FLEX (19G) biopsy needle due to a defect that can cause components to detach and enter the airways during a lung biopsy. This can result in serious health consequences, including bleeding, infection, or death.

How many injuries and deaths have occurred?
As of the FDA’s September 2025 announcement, there have been 14 reported injuries and 1 death linked to the defective biopsy needles.

What injuries are linked to this device?
Documented injuries include mucosal bleeding, foreign body aspiration, retained device fragments, airway inflammation, delayed diagnosis, and fatal complications requiring emergency intervention.

What should I do if I had a lung biopsy in the past two years?
Contact your healthcare provider to find out which biopsy needle was used in your procedure. If you experience coughing, fever, chest pain, or breathing difficulties after your procedure, it is important to undergo further testing—even if the device fragments are not visible on X-rays.

Can I sue Olympus if I was injured?
Yes. You may be eligible to file a product liability lawsuit against Olympus if you suffered harm from a defective ViziShot 2 FLEX device. This includes physical injury, medical costs, missed work, and pain and suffering.

Is the device still on the market?
Olympus has started removing affected devices from the market and sent out Urgent Medical Device Removal notices. However, not all medical facilities may have pulled the affected lots yet.

What is a Class I recall?
A Class I recall is the FDA’s most serious designation, indicating a product defect that can lead to serious injury or death.

Is Parker Waichman LLP accepting new cases?
Yes. Parker Waichman LLP is currently representing individuals nationwide who were injured by defective Olympus biopsy devices and is offering free case evaluations.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one suffered complications after a lung biopsy procedure involving the Olympus ViziShot 2 FLEX 19G needle, you may be eligible to pursue legal action. The national product liability attorneys at Parker Waichman LLP are actively investigating these cases and are here to help.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation. Our firm has recovered billions of dollars for victims of dangerous medical devices and we’re ready to fight for you.