Olympus Corporation has announced a voluntary global recall of certain lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. The recall addresses potential safety risks linked to device components detaching during medical procedures. Healthcare facilities and clinical professionals are urged to act immediately to ensure patient safety is maintained.
Key points:
- The recall affects ViziShot 2 FLEX devices manufactured before May 12, 2025.
- Reports include incidents of adverse events and one patient death.
- Medical professionals must assess abnormal post-procedural symptoms for possible device-related issues.
In this article:
Why is Olympus recalling these devices?
The recall was announced on September 19, 2025, involving ViziShot 2 FLEX needles manufactured before May 12, 2025. Olympus reported cases of device components, including non-radiopaque plastic parts and the hypotube, detaching during clinical use. This could result from damage during usage or manufacturing. To address manufacturing inconsistencies, Olympus replaced manual visual inspections with automated checks.
The recall arose after Olympus received adverse event reports, including patient injuries and one death. Damaged devices may release unintended materials into the tracheobronchial tree during ultrasound-guided procedures.
What are the risks associated with the device?
The primary risks involve retained device parts inside the tracheobronchial tree. These components might require removal through bronchoscopy or surgery. Since some parts are radiolucent, identifying and retrieving them could be challenging.
Potential consequences include:
- Bronchoscopic extraction or surgical intervention may be necessary.
- Risk of infection or prolonged procedure time.
- Impact on patient outcomes, particularly if materials remain undetected.
| Concern | Description |
|---|---|
| Affected lots | Manufactured before May 12, 2025 |
| Automated inspections initiated | May 12, 2025 |
| Adverse events reported | Injury and one death |
What should healthcare professionals do?
Healthcare providers should take the following steps:
- Verify ViziShot 2 FLEX lots in inventory. Quarantine and return affected items following Olympus instructions.
- Monitor patients previously treated with impacted devices for post-procedure symptoms or complications.
- Ensure compliance with standard post-procedural care protocols for patients undergoing EBUS-TBNA procedures.
Olympus has reiterated guidance included in the device manual, emphasizing the need to inspect devices for potential damage before use. Customers seeking assistance are encouraged to contact Olympus Technical Support at 1-800-848-9024, Option 1, or via email at complaints@olympus.com.
FAQ
- What is the ViziShot 2 FLEX used for?
It is designed for fine-needle aspiration (FNA) and biopsy (FNB) of submucosal and extramural lesions in the tracheobronchial tree under ultrasound guidance. - Are there alternative devices available?
Yes, Olympus has confirmed that other EBUS-TBNA needles are unaffected by this recall. - What should I do if I notice post-procedure complications in a patient treated with this device?
If symptoms or abnormal imaging findings occur, assess the patient for retained device components and proceed as clinically indicated. - Can retained device parts always be detected through imaging?
No, some components are not radiopaque and might require careful clinical evaluation to identify.
Conclusion
Olympus has initiated this recall to address patient safety risks associated with specific lots of the ViziShot 2 FLEX device. Adherence to recall instructions and close monitoring of patients are essential to mitigating further issues. For ongoing updates or reporting, healthcare professionals can use the FDA’s MedWatch program.
Disclaimer
This article is intended for informational purposes only. It does not constitute medical or legal advice.
FDA Announcement Link
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-voluntary-recall-specific-lots-vizishot-2-flex-19g-ebus-tbna-needles