Olympus Corporation has expanded its voluntary recall of the ViziShot 2 FLEX (19G) EBUS-TBNA needles due to reports of device components ejecting or detaching during procedures, resulting in patient injury and one death.
What Changed?
The recall expansion includes all lots of the ViziShot 2 FLEX needles, superseding the August 2025 notice that only recalled certain lots of the device.
Background
The ViziShot 2 FLEX is designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration and fine needle biopsy of submucosal and extramural lesions of the tracheobronchial tree.
Device Issues
Investigations revealed that the device heat-shrink material can degrade during clinical use, leading to difficulties in extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components.
Implications
Potential consequences of a detached component include the risk of unintended device components within the tracheobronchial tree, requiring bronchoscopic extraction or surgical removal.
Actions
Users are directed to cease use immediately and quarantine all ViziShot 2 FLEX devices, with customers instructed to return the affected devices to Olympus.
Conclusion
In summary, the expanded recall of the ViziShot 2 FLEX EBUS-TBNA needles is a critical step in ensuring patient safety, and users must take immediate action to cease use and return the affected devices.
Disclaimer
This information is not intended to be legal advice, and professionals should consult the original FDA announcement for detailed information.
FDA Announcement
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-expands-voluntary-recall-vizishot-2-flex-19g-ebus-tbna-needles