Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant medical devices where inaccurate diagnostic values could impact patient care.
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. The recall involves a total of 4,007 devices, all models, specifically Model CORE with part number 400-0100.02. These systems are used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
The recall was initiated because a software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. The agency has classified this recall as Class II.
The affected devices were distributed worldwide, including nationwide in the United States and in various regions of Europe, Japan, Canada, South Africa, and numerous other countries. 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 Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitat
- 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. Part number: 400-0100.02.
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.
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