#United States #Medical Devices #Olympus Corporation #Center Valley #ViziShot 2 FLEX

Olympus Issues Recall for ViziShot 2 FLEX EBUS-TBNA Needles

On September 19, 2025, Olympus Corporation announced a voluntary global recall of specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. This decision comes after the company received alarming reports regarding the detachment of components during medical procedures. The ViziShot 2 FLEX is a specialized medical device used primarily in conjunction with ultrasound endoscopes to perform fine needle aspirations (FNA) and biopsies of lesions located in the tracheobronchial tree.

Background of the Recall

The recall pertains specifically to devices manufactured prior to May 12, 2025. Olympus acted swiftly after it became aware of incidents where device components detached from the needles, posing serious safety risks, including patient injury and even one reported fatality. The ViziShot 2 FLEX features a hypotube and sheath designed to stabilize the needle during use. However, if the sheath is damaged and the device is used, the hypotube may disconnect, causing plastic components to become dislodged within the patient's airway, which could necessitate bronchoscopic retrieval or surgical intervention.

Measures Implemented by Olympus

In response to these events, Olympus has introduced an automated inspection procedure to their manufacturing process, replacing previous visual inspections. This change aims to better detect any potential damage during the assembly of the ViziShot 2 FLEX needles. Despite these improvements, the company is instructing customers to immediately quarantine any affected lots and to return them to Olympus for proper action. Instructions have been communicated as part of the global medical device removal announcement.

Patient Safety is the Priority

The recall is a demonstration of Olympus's commitment to patient safety. The company has reminded healthcare professionals about the importance of verifying the manufacturing date of the needles they use, ensuring they do not utilize any devices produced before the aforementioned date. It emphasized that no specific recommendations for medical care were issued for patients already treated with impacted needles, apart from advising routine post-procedure care. However, Olympus has underscored the necessity for medical providers to consider potential device component retention in patients who exhibit abnormal symptoms post-procedure, especially since some of these components are not detectable through radiographic imaging due to their non-radiopaque nature.

Conclusion

As this situation develops, Olympus urges any healthcare personnel who notice adverse reactions or quality issues related to the ViziShot 2 FLEX needles to report these incidents through the FDA's MedWatch program. This proactive approach is critical in ensuring patient safety and improving the reliability of medical devices. Olympus honors its responsibility to rectify such issues while maintaining clear communication with medical professionals and patients alike. For further assistance or to report problems, users can reach the Olympus Technical Assistance Center.

Call for Action

Patients who have undergone procedures involving the ViziShot 2 FLEX should consult with their healthcare providers for any emerging concerns. Olympus remains steadfast in its mission to enhance the safety and efficacy of its medical equipment, ultimately making health care safer and more reliable.