Olympus Corporation has expanded its global recall of the ViziShot 2 FLEX (19G) EBUS-TBNA needles after reports of device components ejecting or detaching during procedures. The company received complaints that included adverse events resulting in patient injury and one death. This action now includes all lots of the ViziShot 2 FLEX needles, replacing a previous notice from August 2025 that only affected certain lots.
The main risk identified is that detached components could remain inside the tracheobronchial tree, which may require removal through bronchoscopy or surgery. Olympus’ internal investigation since August 2025 found more contributing factors to component ejection, such as degradation of heat-shrink material and user errors. These issues can affect needle performance, potentially leading to problems like fluid leakage, impaired deployment or retraction, difficulty extracting samples, or breakage.
Users are instructed to stop using the devices immediately and quarantine all ViziShot 2 FLEX products. Olympus asks customers to return affected devices according to their instructions. The company stated, "Patient safety is our top priority."
The ViziShot 2 FLEX is used with ultrasound endoscopes for fine needle aspiration and biopsy of lesions in the tracheobronchial tree. Other EBUS-TBNA needles are not impacted by this recall.
Adverse reactions or quality concerns related to this product can be reported to the FDA's MedWatch program online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.
For questions about identifying affected products or reporting problems in the U.S., customers can contact the Olympus Technical Assistance Center at 1-800-848-9024 (Option 1), Monday through Friday from 7:00 AM to 8:00 PM ET, or email complaints@olympus.com.
