Olympus Recalls ViziShot 2 FLEX Endoscopic Aspiration Needle Injury & Wrongful Death Lawsuit Lawyers

Olympus Recalls ViziShot 2 FLEX Endoscopic Aspiration Needles After Reports of Injuries and Death

Medical devices are intended to help diagnose, treat, or manage health conditions safely. When a defect is discovered, the consequences for patients can be catastrophic. That is the case with Olympus’s recall of certain ViziShot 2 FLEX (19G) Endoscopic Aspiration Needles, which the U.S. Food and Drug Administration (FDA) has classified as a Class I recall, the most serious category reserved for devices that may cause severe injury or death.

The recall was initiated after Olympus identified that some of these devices may have deformed a-traumatic tips, posing a risk of breakage, loose components entering the airway, bleeding, infection, and even fatal outcomes. To date, Olympus has acknowledged at least 14 reported injuries and one death linked to the defect. Patients and families affected by this recall may be eligible to pursue legal claims for compensation.

What Is the Olympus ViziShot 2 FLEX Needle?

The ViziShot 2 FLEX (19G) is a tissue biopsy device used during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB). These procedures allow doctors to obtain tissue samples from abnormalities under the mucosal lining or from structures outside the tracheobronchial tree, such as suspected tumors or lymph nodes.

The device is made up of four parts:

• A handle
• A sheath
• A needle
• A stylet

Physicians insert the device through an ultrasound endoscope to reach deep into the airways and collect tissue samples for diagnosis. When functioning properly, the device is critical for detecting serious conditions, including lung cancer. However, the discovery of defects in certain batches raises serious safety concerns for patients who have undergone these procedures.

The Reason Behind the Recall

Olympus initiated the recall because some ViziShot 2 FLEX (19G) devices were manufactured with potentially deformed a-traumatic tips. This flaw increases the risk of:

• Hypotube component ejection: Metal tubing parts may dislodge during use.
• Detached plastic components: Fragments may enter the patient’s airway and become lodged in the lungs.
• Tissue trauma: The deformed tips can cause perforations, mucosal tears, and bleeding.
• Infection: Damaged or irregular tips compromise sterility and can lead to bacterial contamination.

The FDA warned that these risks can result in severe health outcomes, including the need for additional invasive procedures to remove foreign objects, permanent airway damage, and death.

Reported Injuries and Fatality

As of August 2025, Olympus confirmed 14 serious injuries and one death linked to the defective devices. Reported complications include:

• Internal bleeding from mucosal injuries
• Severe airway trauma
• Infection following foreign body entry
• Emergency surgeries to retrieve broken components
• Respiratory distress or collapse

The single fatality underscores the life-threatening nature of the defect. Even when patients survive, the complications can lead to prolonged hospitalizations, long-term medical care, and permanent health consequences.

FDA Classification and Manufacturer Response

The FDA designated this as a Class I recall, the most severe level, reserved for situations where continued use of a device could cause serious injury or death.

On August 6, 2025, Olympus issued an Urgent Medical Device Removal letter to all affected customers. The letter instructed medical facilities to:

• Immediately stop using affected lot numbers.
• Quarantine recalled devices.
• Inspect instruments carefully before and after each use.
• Return affected products to Olympus for credit.

The company also reinforced existing warnings from its Instructions for Use (IFU), cautioning against forcing the device if resistance is encountered during procedures.

Patient Safety Risks

The defective ViziShot 2 FLEX (19G) needles pose multiple risks to patients:

1. Airway Obstruction: Detached components can lodge in the trachea or bronchial tree, requiring emergency removal.
2. Perforation and Bleeding: Sharp or bent tips can tear delicate airway tissues, leading to internal bleeding.
3. Infection: Damaged tips increase the chance of contamination and life-threatening infections.
4. Need for Additional Procedures: Foreign bodies or tissue damage may require further invasive procedures, increasing overall risk.
5. Death: In the most severe cases, complications can be fatal, as already reported.

What Patients Should Know

Patients who underwent an endoscopic biopsy with a ViziShot 2 FLEX needle may not know whether their procedure involved a defective lot number. Medical providers are responsible for reviewing inventory and identifying affected patients. However, patients who experience unusual symptoms following an endoscopic biopsy—such as persistent coughing, chest pain, fever, shortness of breath, or unexplained bleeding—should seek medical evaluation immediately.

The recall covers devices distributed from August 4, 2022, to April 25, 2025, with expiration dates of March 25, 2028, or earlier.

Legal Options for Injured Patients and Families

Patients harmed by defective medical devices may be entitled to financial compensation. Potential claims may include:

• Product Liability: Holding Olympus accountable for manufacturing and distributing a defective medical device.
• Medical Expenses: Coverage for hospitalization, surgery, and long-term treatment.
• Lost Wages: Compensation for time away from work due to injuries.
• Pain and Suffering: Damages for physical pain and emotional trauma.
• Wrongful Death: For families who lost a loved one, compensation may cover funeral costs, lost financial support, and emotional damages.

Because the FDA has already classified this as a Class I recall with documented injuries and a fatality, patients and families may have strong grounds for legal action.

Olympus ViziShot 2 FLEX Needle Recall FAQs

1. What device is being recalled?  The recall affects Olympus ViziShot 2 FLEX (19G) Endoscopic Aspiration Needles manufactured before May 12, 2025. These devices were distributed from August 2022 through April 2025.
2. Why are these devices dangerous?  Some needles have deformed tips that may eject components or cause airway injuries. Risks include bleeding, perforation, infection, foreign body obstruction, and death.
3. How many people have been injured?  At least 14 patients have been injured, and one death has been reported in connection with this defect.
4. What should patients do if they had a procedure with this device?  If you recently underwent a biopsy with a ViziShot 2 FLEX needle, consult your doctor. Report any unusual symptoms, including persistent coughing, chest discomfort, fever, or breathing problems.
5. Do patients need to have the device removed?  The needle is not implanted permanently—it is used during biopsy procedures. However, patients injured during use may require corrective medical treatment.
6. Can I file a lawsuit?  Yes. Patients injured by defective Olympus devices may be eligible for financial compensation through product liability or wrongful death claims.
7. What compensation might be available?  Compensation may cover medical bills, lost wages, pain and suffering, and other damages. Families of deceased patients may pursue wrongful death claims.
8. Do I need proof that the defective lot was used in my procedure?  Medical records and hospital inventory logs can link your procedure to a recalled device. Attorneys can assist in obtaining and reviewing these records.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one suffered injuries after undergoing a biopsy procedure with an Olympus ViziShot 2 FLEX (19G) Endoscopic Aspiration Needle, you may be entitled to significant financial compensation. Parker Waichman LLP is a national personal injury law firm investigating claims connected to this Class I FDA recall.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation. Our attorneys will review your case, explain your rights, and fight to secure the compensation you deserve. Regardless of your location or where your injury occurred, our nationwide defective medical device lawsuit lawyer are ready to assist you.