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All product recalls associated with Volcano Corporation.
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Jan 2022
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.