Olympus (ViziShot 2 FLEX (19G) EBUS -TBNA needles/Olympus Corporation) Recall reason: Device Components May Detach During Procedures

COMPANY ANNOUNCEMENT

Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles

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Summary

Company Announcement

CENTER VALLEY, Pa., (September 19, 2025) - 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.

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.

Olympus notified customers about the issue and requested that customers quarantine devices manufactured before the automated inspection procedure was implemented. Customers are instructed to return affected lots to Olympus by following instructions provided in the global medical device removal action communication. Further, Olympus reinforced existing cautions and warnings contained in the Instructions for Use related to detecting any potential device damage that might lead to component ejection. Patient safety, and addressing potential risks, are our top priorities.

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.

Health care personnel treating patients using an Olympus ViziShot 2 FLEX must ensure they are not using product from the affected lots, which are those manufactured prior to May 12, 2025.

Olympus does not provide recommendations for medical care in patients who were treated with the impacted devices beyond recommending the standard post-procedural care required of patients undergoing these types of procedures. However, users of this device should note that for patients with abnormal symptoms or image findings post-procedure, the potential for unanticipated retained device components should be assessed. It is notable that some of these components are not radiopaque.

Other EBUS-TBNA needles are not affected by this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email [email protected].

• Content current as of:

  09/22/2025

• Regulated Product(s)

  • Medical Devices

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