Olympus Initiates Recall of ViziShot 2 FLEX Needles Due to Safety Concerns

What's Happening?

Olympus Corporation has announced a voluntary recall of specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles, manufactured before May 12, 2025. This decision follows reports of device components detaching during medical procedures, which have led to patient injuries and one reported death. The recall affects devices that were produced prior to the implementation of an automated inspection procedure designed to detect damage during manufacturing. Olympus has instructed customers to quarantine and return affected devices, emphasizing the importance of patient safety and the need to address potential risks associated with the use of these needles.

Why It's Important?

The recall of the ViziShot 2 FLEX needles is significant due to the potential health risks posed by detached components during medical procedures. These components, which are not radiopaque, can remain undetected within the tracheobronchial tree, potentially requiring bronchoscopic or surgical removal. The recall highlights the critical importance of stringent quality control measures in medical device manufacturing to prevent adverse events. Healthcare providers must ensure they are not using affected products, which could impact patient safety and treatment outcomes. The recall also underscores the need for ongoing vigilance and reporting of adverse events to regulatory bodies like the FDA.

What's Next?

Olympus has reinforced existing cautions and warnings in the Instructions for Use to help detect potential device damage. Healthcare providers are advised to follow standard post-procedural care and assess patients for any abnormal symptoms or image findings that may indicate retained device components. Olympus has provided contact information for reporting issues and obtaining further guidance. The company will continue to monitor the situation and may implement additional safety measures as necessary. Stakeholders, including healthcare facilities and regulatory agencies, will likely scrutinize Olympus's response to ensure patient safety and compliance with industry standards.