Olympus announced a voluntary, global medical device removal of certain ViziShot 2 FLEX (19G) EBUS -TBNA (ViziShot 2 FLEX) needles.
The company manufactured affected needles prior to May 12, 2025. It initiated the recall after receiving reports of device components detaching during procedures. Olympus said that it assessed the issue after receiving complaints of adverse events involving patient injury and one death.
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.
A hypotube and sheath protect the ViziShot 2 FLEX, with the hypotube protecting the sheath from the needle tip and providing stability during transit and insertion. Continued device use after damage to the sheath can potentially cause the hypotube to eject from the device. It can eject along with the detached, non-radiopaque plastic components. Damage may also occur during the manufacturing process.
Olympus said that potential consequences include the risk of unintended device components within the tracheobronchial tree. This may require bronchoscopic extraction or surgical removal.
To improve the detection of device damage at the point of manufacturing, Olympus implemented an automated inspection procedure during assembly. This step previously took place through visual inspection.
Olympus notified customers of the issue and requested that they quarantine affected devices before returning them. The company reinforced existing cautions and warnings in the instructions for use.
