Volcano Corporation

Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).

The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.

High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.

High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.

Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.