Olympus ViziShot 2 FLEX (19G) EBUS-TBNA Needle Injury & Wrongful Death Lawsuit Lawyers

Understanding the expanded recall of Olympus ViziShot 2 FLEX needles, the risks of detached components during biopsy procedures, and your options for compensation.

On January 16, 2026, Olympus Corporation announced an expanded global medical device removal action for its ViziShot 2 FLEX (19G) EBUS-TBNA needles after reports of device components detaching during bronchoscopic procedures and causing patient harm. The Food and Drug Administration (“FDA”) published the company’s announcement as part of its public safety reporting system. The expanded action now includes all lots of the ViziShot 2 FLEX needles, replacing a prior recall from August 2025 that covered only specified production lots. According to Olympus, device components such as the hypotube seal and heat-shrink materials may degrade during use, which raises the risk that parts of the needle could break or eject into a patient’s airway. Here is a link to Original Press Release

The potential consequences of such breakage can be serious, including the presence of a detached component in the tracheobronchial tree that may require urgent bronchoscopic extraction or even surgical removal. The company’s communication has directed clinicians and healthcare facilities to cease use immediately and quarantine all affected devices, returning them to the manufacturer as instructed. While Olympus states that patient safety is a top priority, reports of adverse events — including patient injury and at least one death — have triggered concern among clinicians and patients alike.

Understanding what these devices are, how they are used, why the recall was expanded, and what legal options may be available to injured patients or families can help victims protect their rights and pursue compensation where appropriate.

What the ViziShot 2 FLEX (19G) EBUS-TBNA Needle Is and How It Works

The ViziShot 2 FLEX (19G) EBUS-TBNA needle is a medical device designed for use with endobronchial ultrasound (EBUS) endoscopes. It allows physicians to perform ultrasound-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of lesions located in the tracheobronchial tree, including submucosal growths or lesions outside the airway wall. These procedures are commonly used to diagnose lung cancer, lymphoma, sarcoidosis, and other serious pulmonary conditions. During the procedure, the physician advances the needle through the endoscope to sample tissue under real-time ultrasound guidance.

The design of the ViziShot 2 FLEX includes a needle assembly sealed with heat-shrink material that is intended to maintain structural integrity during aspiration and biopsy. The hypotube component provides support and pathway for the internal needle. When these materials degrade or parts detach during a procedure, the clinician may be unable to extract or expel the sample, may encounter fluid leakage, or — in the most serious cases — detached parts may remain inside the patient’s airway. These outcomes can lead to serious complications, including airway obstruction, secondary surgeries, prolonged anesthesia time, infection, bleeding, and other harm.

Why the Recall Was Expanded

In August 2025, Olympus initially issued a recall covering specific lots of the ViziShot 2 FLEX needle based on early complaints of component detachment. Since that communication, Olympus conducted an internal investigation into additional reports and identified further contributing factors related to device performance, particularly heat-shrink material degradation and potential use issues that affect all production lots. As a result, the company expanded the recall to include every unit of the ViziShot 2 FLEX (19G) needle distributed worldwide.

According to the company notice, the heat-shrink seal designed to encase the needle assembly can deteriorate under clinical use conditions. When the seal fails, the needle may not deploy or retract properly, which can interfere with sample collection and may lead to breakage during manipulation. The degradation issues were found across all lots, leading Olympus to take the unusual step of expanding the recall globally rather than continuing the targeted action.

Because the FDA does not endorse specific products or manufacturers when it publishes recall notices, the public announcement serves to alert clinicians, healthcare facilities, and patients to the risks associated with continued use of the device. Healthcare providers have been instructed to quarantine the devices, stop use immediately, and follow return procedures outlined by Olympus.

Potential Injuries and Harms from a Detached Component

When a component of a biopsy needle detaches inside the airway, the consequences can be serious and require urgent medical intervention. Potential harms associated with detached elements of the ViziShot 2 FLEX needle include:

• Retained foreign body in the tracheobronchial tree, which may not be visible on standard imaging and requires bronchoscopic retrieval.
• Secondary surgical procedures to locate and remove the detached part, increasing anesthesia time and surgical risk.
• Airway trauma or bleeding during attempted extraction.
• Infection or inflammation if the foreign body is not immediately removed.
• Prolonged hospitalization, including time in intensive care.
• Respiratory complications such as decreased lung function or aspiration events.
• Death in the most severe cases, when additional complications arise or extraction is delayed.

These outcomes extend beyond the initial diagnostic procedure and may require follow-up treatments, additional surgical interventions, extended recovery time, and substantial medical costs.

Who May Be Affected and What to Do If You Were Harmed

Patients who underwent EBUS-TBNA procedures using the ViziShot 2 FLEX (19G) needle may not be aware that the device used on them has been part of a recall. Many individuals undergoing bronchoscopy are in already vulnerable health conditions or have compromised pulmonary status, which can amplify the risk of complications arising from a detached component. If you experienced unusual symptoms after an EBUS procedure involving this device — such as persistent coughing, shortness of breath, chest discomfort, bleeding, fever, difficulty breathing, or repeated hospital visits — it may be related to the device malfunction.

It is important for patients and families to:

• Document all symptoms and clinical events following the procedure
• Obtain medical records related to the biopsy and any follow-up interventions
• Note whether the specific needle used was a ViziShot 2 FLEX (19G) model
• Track all medical bills, lost wages, and related costs associated with treatment
• Consult with a qualified medical device injury attorney to evaluate whether the harm may be compensable

Because the recall includes all lots, proof of the exact production run may not be required; however, documentation that the ViziShot 2 FLEX was used during your procedure will be important for any potential injury claim.

Legal Basis for Claims Against the Manufacturer

Patients harmed by a defective medical device may be able to pursue compensation through a product liability claim against the manufacturer. In a medical device recall case such as the ViziShot 2 FLEX expanded action, potential legal claims may include:

Defective design

If the device’s structural design allowed for heat-shrink degradation and detachment during normal clinical use, plaintiffs may argue the design was unreasonably dangerous.

Manufacturing defect

A claim may assert that the device deviated from its intended specifications due to manufacturing errors that created a hazard.

Failure to warn

Patients and healthcare providers may not have been adequately warned about the risk of component detachment, or the warnings may not have adequately described the magnitude of possible harm.

Negligence

Beyond product liability, claims may allege that Olympus failed to properly monitor post-market complaints, test materials under realistic use conditions, or take timely action to protect patients once early reports of detachment surfaced.

Successful claims may compensate harmed plaintiffs for medical expenses, lost income, pain and suffering, disability, and other impacts stemming from the device injury.

Damages Available in ViziShot 2 FLEX Needle Injury Claims

Victims of device malfunction may recover compensation for a range of losses. These can include:

Medical Expenses

Costs associated with additional procedures, hospital stays, diagnostic imaging, physical therapy, emergency interventions, and long-term care related to complications from a detached component.

Lost Wages and Lost Earning Capacity

If injury from the device interfered with your ability to return to work or perform at the same level as before, you may be compensated for lost income and future earnings.

Pain and Suffering

Injuries from retained foreign bodies and subsequent surgeries can cause significant physical pain, emotional distress, anxiety, and diminished quality of life.

Disability or Impairment

Permanent impairments affecting breathing, physical stamina, or pulmonary function may qualify for additional damages reflecting the long-term impact on daily living.

Funeral and Burial Costs

In cases where wrongful death results from device complications, surviving family members may pursue damages for funeral costs, loss of financial support, and loss of companionship.

An attorney can help document each category of loss so that the claim reflects the full impact of the injury on you and your family.

Why You Should Consider Legal Representation

Medical device injury claims involve technical facts, product design details, material science, clinical practice standards, and regulatory compliance history. Hospitals and manufacturers typically have legal teams ready to defend against claims, and insurance companies often seek to limit payouts. Having a dedicated product liability attorney can make a material difference in how a case is presented, how evidence is gathered, and how damages are calculated.

A qualified attorney can:

• • Review your medical records and device use documentation
  • Help identify whether the ViziShot 2 FLEX needle was involved
  • Coordinate with medical specialists for opinion evidence

• Handle communications with insurers and corporate defense counsel
• File necessary pleadings and protect your legal rights
• Pursue fair compensation based on the full extent of your injuries

Legal representation can provide clarity about your rights and options, ensure deadlines such as statutes of limitations are met, and relieve you and your family of legal procedural burdens while your claim moves forward.

ViziShot 2 FLEX Lawsuit FAQs

What should I do if I was injured after a biopsy using the ViziShot 2 FLEX needle?

If you experienced complications after an EBUS-TBNA procedure with the ViziShot 2 FLEX needle, you should obtain your medical records, note all symptoms and treatments, contact your treating physicians for documentation of suspected device-related harm, and consider contacting a medical device injury attorney who can evaluate whether you have a legal claim.

Can I still pursue a claim if the procedure happened months ago?

In many states, there are time limits (statutes of limitations) for filing injury claims. These deadlines vary depending on where you live and when you discovered your injury. An attorney can review your situation to determine whether you still have the right to file a lawsuit.

What types of compensation are available?

Victims of a defective medical device like the ViziShot 2 FLEX needle may recover economic damages (such as medical bills and lost income) and non-economic damages (such as pain and suffering). In some cases, punitive damages may be available when the defendant’s conduct was particularly careless or reckless.

Do I need to prove the exact lot number of the device?

Because the recall now includes all lots of the ViziShot 2 FLEX needle, proving the specific lot number may not be necessary. What matters most is demonstrating that the device was used in your procedure and that you suffered injury linked to its malfunction.

Will a lawsuit take a long time to resolve?

The timeline for a medical device injury lawsuit varies by case complexity, court schedules, and whether the case settles or goes to trial. Many cases resolve through negotiated settlements, but some may proceed to trial if necessary to obtain fair compensation.

Can hospitals be held responsible too?

In some situations, hospitals or clinicians may share liability if there was negligence in using, inspecting, or responding to a known device issue. An attorney can evaluate all potential responsible parties.

How is pain and suffering calculated?

Pain and suffering damages are based on the physical and emotional toll of your injury, including discomfort, anxiety, loss of enjoyment of life, and other non-economic impacts. An attorney will help document these losses.

Contact Parker Waichman LLP For a Free Case Review

If you or someone you know was harmed after a biopsy procedure involving the Olympus ViziShot 2 FLEX (19G) EBUS-TBNA needle, you may be entitled to compensation for medical costs, lost income, pain, suffering, and other damages. Parker Waichman LLP represents patients and families nationwide who have suffered injury from defective medical devices. Our attorneys will review your case at no cost, explain your legal rights, and help determine whether you may be eligible to pursue a claim.

Call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation.