Olympus Issues Voluntary Recall for ViziShot 2 FLEX Needles: What Patients & Providers Should Know

On September 19, 2025, Olympus Corporation announced a global voluntary medical device removal action for certain lots of the ViziShot 2 FLEX (19G) EBUS-TBNA needles that were manufactured prior to May 12, 2025. This recall stems from reports that components of the device may detach during procedures, posing serious safety risks to patients. Below, we break down what went wrong, how Olympus is responding, and what patients and providers should watch for.

What Is the ViziShot 2 FLEX & How It’s Used

The ViziShot 2 FLEX needle is used with ultrasound endoscopes to perform fine needle aspiration (FNA) and fine needle biopsy (FNB) of lesions in or around the tracheobronchial tree (the airways of the lungs). In other words, doctors use it to sample suspicious tissue under ultrasound guidance for diagnosis, especially in lung cancer or other respiratory lesions.

The ViziShot 2 FLEX includes a hypotube and sheath which stabilize the device and protect the needle tip during insertion.The sheath helps preserve the structural integrity of the needle apparatus during transit and use.

What Went Wrong: Detaching Components & Ejection Risks

The core defect involves parts of the device—namely, the hypotube or plastic assemblies—potentially ejecting during a biopsy procedure if the sheath has been damaged or compromised. Because some of the plastic components are not radiopaque, they aren’t visible on standard X-ray imaging.

In practice, this means:

• A damaged sheath can allow the hypotube or plastic parts to become loose.

• The detached or ejected components could end up in a patient’s airway (the tracheobronchial tree).

• If that happens, the foreign parts might require bronchoscopic (via a scope) extraction or even surgical removal.

• Worse, patients may suffer from mucosal injury, bleeding, infection, or other complications from retained fragments.

Because many of the plastic parts are invisible on X-rays, doctors may not immediately detect that something has gone wrong—a silent but hazardous risk.

Olympus believes some device damage may occur during manufacturing—not only during use.

In response, the company has shifted from a visual inspection to an automated inspection step during assembly to better identify defects before distribution.

Reported Injuries, Including One Death

As part of its assessment, Olympus acknowledged adverse event reports involving patient injury and one death tied to the ViziShot 2 FLEX device. The company did not always specify details publicly, but the severity underscores the potential danger.

There have been 14 injuries associated with the recall, in addition to the one death.

Olympus’s Response & Recall Actions

To manage the risk, Olympus has taken several steps:

• Instructed customers to quarantine all ViziShot 2 FLEX (19G) devices from affected lots (manufactured before May 12, 2025).

• Asked facilities to return the affected lots per Olympus’s removal instructions.

• Reinforced existing warnings in the device Instructions for Use (IFU), urging operators to inspect for damage before each pass and avoid forcing the needle if resistance is felt.

• Instituted automated inspection procedures in manufacturing to catch defective parts earlier.

• Emphasized that other EBUS-TBNA needle devices are not affected by this recall.

The recall has also been categorized as a Class I recall, the most serious type, meaning continued use of the product poses a risk of serious injury or death. American Hospital Association

What Patients & Providers Should Do

For Providers / Hospitals / Clinics:

• Immediately check inventory and quarantine any ViziShot 2 FLEX needles from affected lots.

• Do not use those devices.

• Review the reinforced IFU warnings: stop if resistance is felt, inspect the instrument for irregularities, and never force insertion.

• Return the devices to Olympus according to the recall instructions.

• Educate all staff involved in lung biopsy or EBUS procedures about the recall and risk.

For Patients Who Already Had a Procedure:

• If you develop unusual or unexpected symptoms after an EBUS biopsy, especially respiratory distress, coughing up fragments, bleeding, or persistent pain, ask your physician whether retained device components might be the cause.

• Be aware that stray parts may not show on standard X-rays, so advanced imaging or bronchoscopy may be required.

• Report any adverse events or complications through your physician to FDA MedWatch or the device manufacturer.

Legal Implications & KBD’s Commitment

This recall raises serious questions of product liability, failure to warn, and manufacturing negligence. The possibility of device fragments being left inside patients, some of which are invisible on imaging, intensifies the risk and potential for harm.

At KBD Attorneys, we monitor recalls like this closely. If you or a loved one underwent a biopsy using a ViziShot 2 FLEX needle and later experienced complications, we can help you understand whether you may have a claim. Our goal is to ensure manufacturers are held accountable when device defects lead to patient injury.

Bottom Line

The Olympus ViziShot 2 FLEX recall is serious—components detaching during lung biopsy or FNA procedures pose direct harm to patients. Olympus’s steps to quarantine, recall, and revise inspection protocols are important but may not undo harm already caused.

If you or someone you care about underwent a procedure involving this device and experienced complications, reach out. You should not have to navigate complex medical or legal challenges alone—KBD is here to help.

Sources:

olympus-global

medtechdive

FDA

Amercian Hosptial Association