Volcano Corp IntraSight Mobile IVUS Systems Missing Critical Labels
Volcano Corp recalls IntraSight Mobile IVUS Systems Model 797415 with missing labeling for safety. Affected units include specific part numbers and device identifiers.
Lower-risk recall
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.
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What happened, in plain English
Volcano Corp is recalling IntraSight Mobile IVUS Systems Model 797415 due to missing critical labels on the Multi-Modality Touch Screen Modules. This could lead to improper use or safety issues if the device isn't properly identified. Read more at govinfonow.com/recall/61228-volcano-corp-intrasight-mobile-ivus-systems-missing-critical-labels.
Source Summary by GovInfoNow · govinfonow.com/recall/61228-volcano-corp-intrasight-mobile-ivus-systems-missing-critical-labels · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0901-2022
Cite this page
“Volcano Corp IntraSight Mobile IVUS Systems Missing Critical Labels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61228-volcano-corp-intrasight-mobile-ivus-systems-missing-critical-labels. Based on FDA recall #Z-0901-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0901-2022%22&limit=1).
Why it’s dangerous
The Multi-Modality Touch Screen Modules (MM-TSM) are missing required labeling information such as the Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference. This could cause confusion or improper use if the device isn't correctly identified.
Who’s affected
Healthcare professionals using the IntraSight Mobile IVUS Systems are most at risk. Patients using these systems may also be affected if the device isn't properly labeled.
How to tell if you have this one
Check for the model number 797415 and part numbers 300002018101 or 300002018102. Also look for the Device Identifier (DI) 00845225012915 on the MM-TSM units.
- Brand
Volcano Corp- Category
Medical device
What to do — step by step
Check Labels
Verify if the MM-TSM units have the required labels including Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.
Where it went and when
Where it was distributed
Distributed in 14 states.
FDA distribution: “US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Georgia, Maryland, Massachusetts, Missouri, New York, North Carolina, Oregon, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0901-2022 (January 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0901-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.