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 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, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
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 the Model s5i with part number 806300-020.
The recall was initiated because a software issue was discovered where an inaccurate Fractional Flow Reserve (FFR) or instantaneous FFR (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 nationwide in the United States and in various regions of Europe, Asia, Africa, and the Americas. Users of these devices should contact Volcano Corporation for further instructions regarding 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 s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitati
- 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 s5i. Part number: 806300-020.
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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