Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
IntraSight Mobile IVUS Systems Recalled by Volcano Corp Due to Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary...
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 Corp directly.
Affected Products
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Quantity: 47
Why Was This Recalled?
Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.
Where Was This Sold?
This product was distributed to 15 states: AZ, CA, CO, DE, FL, GA, MD, MA, MO, NY, NC, OR, PA, TN, TX
About Volcano Corp
Volcano Corp has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report