Recall notice
ViziShot 2 FLEX (19G) EBUS -TBNA needles recalled due to Device Components May Detach During Procedures, USA
3 months ago •source fda.gov
United States
Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures.The ViziShot 2 FLEX is protected by a hypotube and sheath. The hypotube protects the sheath from the needle tip and provides stability during transit and insertion. If damage to the sheath has occurred and the device continues to be used, the hypotube has the potential to eject from the device along with detached plastic components, which are not radiopaque. Damage may also occur during the manufacturing process. To improve the detection of device damage at the point of manufacturing, Olympus implemented an automated inspection procedure during assembly, a step that had been conducted previously through visual inspection.
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.
Olympus assessed the issue after receiving complaints of adverse events involving patient injury and one death. Potential consequences of a detached component of the ViziShot 2 FLEX include the risk of unintended device components within the tracheobronchial tree that may require bronchoscopic extraction or surgical removal.
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-voluntary-recall-specific-lots-vizishot-2-flex-19g-ebus-tbna-needles
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