Olympus Corporation has announced a voluntary global recall of specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. These needles are used in ultrasound-guided fine needle aspiration and biopsy procedures. The recall comes after reports of device components detaching during procedures. For clinical, regulatory, and quality teams, this announcement highlights critical safety concerns that demand immediate attention.
What Changed?
The affected Olympus ViziShot 2 FLEX needles were manufactured prior to May 12, 2025, before an automated inspection procedure was implemented in the manufacturing process. Reports indicate that components of the device, including the hypotube and detached plastic parts, could eject during procedures if the sheath is damaged. These components are not radiopaque, complicating their detection during post-procedure evaluations.
Reported Incidents and Potential Risks
Olympus received complaints of adverse events linked to the ViziShot 2 FLEX needles. These incidents include patient injuries and one reported death. Detached components may end up within the tracheobronchial tree, possibly requiring bronchoscopic extraction or surgical intervention. Such events underscore the significant risk to patient safety associated with these needles.
Updates to the Manufacturing Process
The automated inspection procedure introduced by Olympus during assembly aims to more effectively detect device damage, which was previously identified through manual visual inspection. This improvement reflects an enhanced focus on preventing risks associated with damage to the sheath and subsequent component failure.
Who Is Affected?
Healthcare professionals using the ViziShot 2 FLEX needles must ensure that products from affected lots are removed and quarantined. Lots manufactured before May 12, 2025, are subject to the recall. Olympus has reached out to customers, providing instructions for safely returning affected products.
It is important to note that no other EBUS-TBNA needles from Olympus are part of this recall.
Guidance for Patients
Olympus has stated that standard post-procedural care remains sufficient for patients treated with these devices. However, for patients presenting abnormal symptoms or imaging findings after the procedure, an evaluation for potential retained device components is recommended. Clinicians should remain vigilant, as some plastic components of these devices are not radiopaque, increasing diagnostic challenges.
Conclusion
This voluntary recall underscores Olympus’s commitment to patient safety and its proactive measures to address identified risks. Healthcare professionals are urged to review affected product lots and follow recall instructions to maintain the highest standards of care.
Disclaimer
This information is provided for clinical, regulatory, and quality teams and is not intended as legal advice. Always consult with appropriate professionals for compliance-related inquiries.
Mandatory FDA Line
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