Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software defect that could lead to inaccurate diagnostic values (FFR/iFR), which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems, including software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits, as well as the Model CORE Mobile. The recall involves a total of 4,007 devices.
The recall is being conducted because a software issue was discovered where an inaccurate Fractional Flow Reserve (FFR) or Instantaneous Wave-free Ratio (iFR) value could be calculated under certain circumstances. These systems are used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
The affected devices were distributed worldwide, including the United States, regions in Europe, and numerous countries in Asia, Africa, South America, and the Middle East. Healthcare providers and facilities using these systems should contact Volcano Corporation for further instructions on how to address the software issue.
The recalled product
- Product
- 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 qu
- Manufacturer
- Volcano Corporation
- Affected units
- 4,007
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model CORE Mobile. Part number: 400-0100.01.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Volcano Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Volcano Corporation
See all →- HighSyncVision Systems cardiac imaging measurement error in same-session workflow
FDA (Devices) · 2022-04-13
- ModerateVolcano FFR Software Recalled for Interoperability Issues with Hemodynamic Systems
FDA (Devices) · 2019-12-18
- ModerateVolcano Visions PV .035 Digital IVUS Catheter Recall for Guidewire Issue
FDA (Devices) · 2019-01-23
- ModerateVolcano Visions PV .035 Digital IVUS Catheter Recalled for Guidewire Issue
FDA (Devices) · 2019-01-23
- ModerateVolcano CORE M2 Vascular System Recalled for Incorrect Resistor
FDA (Devices) · 2018-05-23
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25