Olympus Endoscope Needle Recall Issued Following Patient Death

Federal officials warn that pieces of specialized needles used in endoscopic procedures could break off during use and enter a patient’s airway.

Medical device manufacturer Olympus is recalling certain ViziShot 2 FLEX endoscope needles, due to concerns that components may detach during procedures, creating a risk to patient safety.

The U.S. Food and Drug Administration (FDA) issued the Olympus ViziShot 2 FLEX endoscope needle recall on September 22, warning that detached components could come loose in patients’ airways, potentially requiring removal through additional procedures or surgeries.

ViziShot 2 FLEX endoscopic needles are used with specialized scopes to collect tissue samples from the lungs and airways, helping doctors diagnose cancers, growths or other abnormalities.

The devices are equipped with a sheath and a hypotube, which protects the sheath from the needle tip and provides stability during transit and insertion. However, if the sheath is damaged and the device continues to be used, the hypotube may eject along with other plastic components into the patient’s airway, potentially leading to severe injuries or death.

Olympus has received multiple adverse event reports involving its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before May 12, 2025, including patient injuries and one reported death.

In response, the company has replaced its previous visual inspection process with an automated inspection system during assembly to better detect potential defects. Olympus has also notified customers, directing them to quarantine any affected devices and return them by following the instructions provided in the company’s correspondence.

The warnings in the device Instructions for Use have also been reinforced to highlight the importance of checking for any potential damage that could cause components to detach. 

While Olympus does not recommend any special follow-up care for patients beyond standard post-procedure monitoring, the company advises clinicians to consider the possibility of ejected device pieces if patients develop unusual symptoms or abnormal imaging findings. Olympus further notes that some of these components may not be visible on X-rays or other imaging tests.

For more information, customers can contact Olympus Technical Assistance Center at 1-800-848-9024 or via email at complaints@olympus.com.

Dangers of Olympus Endoscopes

This is not the first time Olympus has experienced quality issues with its medical devices. The company recalled single-use endoscope guide sheath kits earlier this year, after detached tips inside patients caused dozens of serious injuries.

Last year, Olympus issued a recall of certain endoscopes due to bacteria contamination, which led to at least 120 patient injuries and one death.

Olympus also recalled certain bronchoscope medical tubes in 2023, which were linked to nearly 200 reports of the tubes catching fire in operating rooms. That same year, federal regulators issued a warning to Olympus Medical Systems for failing to comply with quality control and reporting standards tied to prior deadly infection outbreaks.

In March 2023, the FDA issued a separate warning letter after the company failed to address quality issues linked to repeated problems with duodenoscopes. 

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