Volcano Corp: Medical Device Recall in 2015 - (Recall #: Z-2043-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

Product Classification:

Class II

Date Initiated: September 23, 2013

Date Posted: July 15, 2015

Recall Number: Z-2043-2015

Event ID: 71404

Reason for Recall:

A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.

Status: Terminated

Product Quantity: 227 total units affected by the issue - all models

Code Information:

s5 Part number 804200-002 and 804200-014; s5x Part number 807300-001; CORE MOBILE Part Number 400-0100.01. All software versions

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated