Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model CORE Mobile. Part number: 400-0100.01.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 Corporation
- Reason for Recall:
- A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature
Product Codes/Lot Numbers:
Model CORE Mobile. Part number: 400-0100.01.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2133-2015
Related Recalls
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"
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications