Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller) Recalled by Volcano Corp Due to Multi-Modality Touch Screen Modules (MM-TSM), used with integrated...

Date: February 3, 2022
Company: Volcano Corp
Status: Ongoing
Source: FDA (Device)

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

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

Quantity: 1358

Why Was This Recalled?

Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (50 states)Not affected

About Volcano Corp

Volcano Corp has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report