On August 6, 2025, Olympus issued an urgent recall for specific lots of its ViziShot 2 FLEX (19G) Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) devices, citing critical safety concerns that affect patients and users.
What changed?
Olympus identified a defect in some ViziShot 2 FLEX (19G) needles manufactured before May 12, 2025. The recall involves products with potentially deformed a-traumatic tips, which could lead to components detaching during use. Detached parts, including hypotube components or plastic fragments, can enter the airway (tracheobronchial tree) and may require medical intervention for removal.
Who is affected?
The recall impacts facilities and healthcare professionals using these devices for procedures such as ultrasound-guided fine needle aspiration or biopsies. Affected devices were distributed in the United States between August 4, 2022, and April 25, 2025, with an expiration date of March 25, 2028, or earlier. Physicians and quality assurance teams must immediately confirm inventory and quarantine potentially defective devices.
What are the risks?
Using a defective ViziShot 2 FLEX (19G) needle poses serious risks to patients, including:
- Mucosal injury and bleeding
- Severe infection or inflammation
- Additional invasive procedures to retrieve detached components
- Death in extreme cases
According to Olympus and the FDA, 14 injuries and one fatality have been reported in association with this issue.
Manufacturer guidance
Olympus has reinforced the instructions for use (IFU) and provided specific warnings to help users avoid incidents:
- Do not forcibly insert the needle or push the slider if resistance is encountered.
- Confirm that the instrument is free from irregularities after each use.
- If any deformation or inconsistency is found, replace the device with a spare.
If devices from affected lots were inadvertently used, carefully inspect them post-procedure for missing components.
Actions required
Healthcare providers are instructed to:
- Examine their inventory and quarantine devices listed in Attachment 1.
- Contact Olympus Customer Service at 1-800-848-9024, option 2, for a Return Material Authorization and credit issuance.
- Distribute this information to relevant teams and any secondary recipients of affected products.
How to report adverse events
Adverse reactions or quality issues linked to these devices can be reported through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Implications and next steps
This recall underscores the importance of rigorous device inspections and adherence to IFU protocols to protect patient safety. Healthcare professionals must act swiftly to remove affected products from circulation and ensure compliance with Olympus and FDA safety guidelines.
Disclaimer
This article is intended for informational purposes for clinical, quality, and regulatory teams. It does not constitute legal or medical advice. For specific guidance, consult Olympus or regulatory authorities.