ViziShot 2 FLEX (19G) EBUS -TBNA needles
Product details
- ViziShot 2 FLEX (19G) EBUS -TBNA needles
Company announcement
Olympus Corporation has expanded a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles after receiving complaints of device components ejecting or detaching during procedures.
This action includes all lots of the ViziShot 2 FLEX needles and supersedes the August 2025 notice.
One death and patient injuries have been reported.
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.