🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: January 24, 2022 Volcano Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    All MM-TSM units, Device Identifier (DI): 00845225012915
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Volcano Corp
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0901-2022

Related Recalls

Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.

Volcano

Class I - Dangerous

Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"

Jun 13, 2025 Surgical Instruments Nationwide View Details →