Olympus announced a voluntary, global medical device removal action for its ViziShot 2 FLEX (19G) EBUS -TBNA needles manufactured before May 12, 2025, after receiving reports of device components detaching during procedures.

The ViziShot 2 FLEX is designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

VisiShot 2 FLEX is protected by a hypotube and sheath. The hypotube protects the sheath from the needle tip and offers stability during transit and insertion. If damage to the sheath has occurred and the device continues to be used, the hypotube could eject from the device along with detached plastic components, which aren’t radiopaque.

To improve detecting device damage at the point of manufacturing, Olympus enacted an automated inspection procedure during assembly. The step had originally been conducted through visual inspection.

Olympus evaluated the issue after receiving complaints of adverse events involving patient injury, and one death. Possible consequences of a detached component include risk of unintended device components in the tracheobronchial tree that could need bronchoscopic extraction or surgical removal.

The company notified customers and requested they quarantine devices manufactured before the automated inspection procedure was enacted. Affected lots should be returned to Olympus by following instructions in the global medical device removal action communication.

Olympus didn’t offer recommendations for medical care in patients treated with the impacted devices, beyond recommending standard post-procedural care. However, users should note that for patients with abnormal symptoms or image findings post-procedure, the possibility for unanticipated retained device components should be evaluated.

The company said other EBUS-TBNA needles aren’t affected by this action.