Olympus Recalls ViziShot 2 FLEX Needles for Safety Concerns
This recall was posted 2 months ago. Check the FDA source for the latest status.
Class I Recall — Most Serious
This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.
Reported Health Impact
1
Death
Olympus Corporation has expanded its recall of ViziShot 2 FLEX (19G) EBUS-TBNA needles due to safety concerns. The recall now includes all lots of the product after reports of device components detaching during procedures, leading to patient injuries and one death.
Products Affected:
- ViziShot 2 FLEX (19G) EBUS-TBNA needles
Reason for Recall:
The recall was issued after complaints revealed that parts of the needle could eject or detach, potentially leaving components in the tracheobronchial tree. This could necessitate bronchoscopic or surgical removal. Investigations found that degradation of the device's heat-shrink material and user errors contributed to these issues.
Consumer Guidance:
Consumers are advised to stop using the ViziShot 2 FLEX needles immediately and quarantine all affected devices. They should return the products to Olympus as per the instructions in the recall communication. For assistance, consumers can contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1, or email [email protected].
Health Risks:
There have been reports of patient injuries and one death associated with the use of these needles. Any adverse reactions or quality problems should be reported to the FDA's MedWatch program.
Where Products Were Sold
This recall affects products distributed nationwide across the United States.