ViziShot 2 FLEX (19G) EBUS -TBNA needles

  • Device Components May Detach During Procedures
  • Company: Olympus Corporation
  • Medical Devices
  • FDA
  • September 19, 2025

Product details

  • ViziShot 2 FLEX (19G) EBUS -TBNA needles

Company announcement

Olympus Corporation has initiated a global medical device removal action for specific lots of ViziShot 2 FLEX needles manufactured before May 12, 2025.

This action follows reports of device components detaching during medical procedures.

One death has been reported in connection with this issue.

Risk:

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.

Impacted states: Nationwide

Products:

- ViziShot 2 FLEX (19G) EBUS -TBNA needles (UPC code(s): N/A)

Contact

For more information, call 1-800-848-9024, Option 1 or email complaints@olympus.com.

View the original FDA notice

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