Olympus Corporation has initiated a voluntary global recall of certain lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. The recall affects devices manufactured before May 12, 2025, following reports that some components detached during medical procedures.
The company explained that the ViziShot 2 FLEX needle is protected by a hypotube and sheath. The hypotube stabilizes the device during insertion and protects the sheath from the needle tip. If damage occurs to the sheath, continued use could result in the hypotube and non-radiopaque plastic components being ejected from the device. Olympus noted that such damage may also happen during manufacturing.
To address this issue, Olympus implemented an automated inspection process at assembly, replacing previous visual checks to better detect any device damage before distribution.
The recall was prompted after complaints were received regarding adverse events, including patient injuries and one reported death. According to Olympus, detached components could remain inside a patient's tracheobronchial tree and might require removal via bronchoscopy or surgery.
"Olympus notified customers about the issue and requested that customers quarantine devices manufactured before the automated inspection procedure was implemented. Customers are instructed to return affected lots to Olympus by following instructions provided in the global medical device removal action communication. Further, Olympus reinforced existing cautions and warnings contained in the Instructions for Use related to detecting any potential device damage that might lead to component ejection. Patient safety, and addressing potential risks, are our top priorities."
Healthcare providers are advised not to use ViziShot 2 FLEX needles from affected lots and should return them according to Olympus's instructions. While no specific recommendations were given for patients already treated with these devices beyond standard post-procedural care, users are urged to assess for retained device components if abnormal symptoms or imaging findings occur after procedures.
The company emphasized that other EBUS-TBNA needles remain unaffected by this recall action.
Adverse reactions or quality issues related to this product can be reported through the FDA’s MedWatch program at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.
For additional information or concerns about this device, healthcare professionals can contact Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) or email complaints@olympus.com.
