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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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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