Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volcano brand Intravascular Ultrasound Recalled by Volcano Corporation Due to The display on the system has the potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Volcano Corporation directly.
Affected Products
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.
Quantity: 1020 units
Why Was This Recalled?
The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
Where Was This Sold?
Worldwide Distribution.
About Volcano Corporation
Volcano Corporation has 22 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report