Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5, s5i, and 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 3/5 (High).
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 involves a medical device with a software defect that could lead to inaccurate diagnostic values (FFR/iFR). This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Volcano Corporation is recalling Volcano s5, s5i, and CORE Intravascular Ultrasound Systems, including software versions 3.3 and 3.4 and Model s5x. The recall involves a total of 4,007 devices distributed worldwide, including the United States, Europe, and various other countries.
The recall was initiated 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 coronary arteries and peripheral vasculature.
Healthcare providers and facilities using these devices 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 s5x. 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 s5x. Part number: 807300-001.
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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