Volcano Corp
San Diego, CA
This page shows every FDA and USDA recall linked to Volcano Corp. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
9
Total Recalls
2013
First Recall
2025
Most Recent
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF...
Jul 30, 2025
· Device
Open, Classified
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
May 16, 2022
· Device
Terminated
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
May 13, 2022
· Device
Open, Classified
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
May 13, 2022
· Device
Open, Classified
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102...
Feb 3, 2022
· Device
Open, Classified
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Jan 24, 2022
· Device
Open, Classified
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging
and Pressure System;
Product/Part numbers: s5i -80...
Jul 8, 2015
· Device
Terminated
ComboMap Intravascular Flow and Pressure System;
Product/Part number: Combo Map - 802745-001.
Intravascul...
Jul 8, 2015
· Device
Terminated
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 80...
Jul 8, 2015
· Device
Terminated