Volcano Corp: Medical Device Recall in 2022 - (Recall #: Z-0901-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

Product Classification:

Class III

Date Initiated: January 24, 2022

Date Posted: April 20, 2022

Recall Number: Z-0901-2022

Event ID: 89677

Reason for 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.

Status: Ongoing

Product Quantity: 47

Code Information:

All MM-TSM units, Device Identifier (DI): 00845225012915

Distribution Pattern:

US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT

Voluntary or Mandated:

Voluntary: Firm initiated