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Volcano Recalls

31 recalls on record · September 19, 2012 to August 6, 2025 · Medical Devices

Recalls by year

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25

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

September 19, 2012Medical DevicesFDA

Volcano Corporation recalls Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-

Hazard: The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.