Olympus has expanded a previous global medical device removal action for its ViziShot 2 FLEX (19G) EBUS -TBNA needles.

This action was made after receiving and investigating complaints of device components ejecting or detaching during procedures. The complaints included adverse event reports of patient injury and one death.

This action includes all lots of the ViziShot 2 FLEX needles and supersedes the August 2025 notice, in which only certain lots of the device were being recalled. Possible consequences of a detached component include risk of unintended device components in the tracheobronchial tree that may need bronchoscopic extraction or surgical removal.

Since the August 2025 notice, internal investigations of complaints identified further contributing factors to hypotube component ejection including device heat-shrink material degradation and use errors. The heat-shrink material sealing the needle can degrade during clinical use and can cause difficulty in extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components.

Olympus directed users to stop use immediately and quarantine all ViziShot 2 FLEX devices. Customers were advised to return affected devices to Olympus by following instructions provided in the removal action communication.

The ViziShot 2 FLEX is designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration and fine needle biopsy of submucosal and extramural lesions of the tracheobronchial tree. Other EBUS-TBNA needles are not affected by this action.