Volcano recalls

Volcano appears in 31 official U.S. recall notices indexed by RecallRadar, most recently on 2025-08-06.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
  FDA Device · Class II · 2025-08-06 · Volcano
• Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
  FDA Device · Class III · 2022-07-06 · Volcano
• Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
  FDA Device · Class III · 2022-07-06 · Volcano
• Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
  FDA Device · Class II · 2022-06-22 · Volcano
• IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
  FDA Device · Class III · 2022-04-20 · Volcano
• MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integr…
  FDA Device · Class III · 2022-04-20 · Volcano
• SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
  FDA Device · Class II · 2022-04-13 · Volcano
• Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems…
  FDA Device · Class II · 2019-12-18 · Volcano
• Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Cathet…
  FDA Device · Class II · 2019-01-23 · Volcano
• Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Cathet…
  FDA Device · Class II · 2019-01-23 · Volcano
• Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only
  FDA Device · Class II · 2018-05-23 · Volcano
• Volcano Imaging System s5i REF 807400001
  FDA Device · Class II · 2017-12-06 · Volcano
• Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter
  FDA Device · Class II · 2017-04-19 · Volcano
• Refinity Rotational Intravascular Ultrasound (IVUS) Catheter
  FDA Device · Class II · 2017-04-19 · Volcano
• Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits
  FDA Device · Class II · 2016-06-01 · Volcano
• Volcano SpinVision Sterile Equip cover II
  FDA Device · Class II · 2016-03-09 · Volcano
• Volcano R100 Sterile Equipment Cover
  FDA Device · Class II · 2016-03-09 · Volcano
• Volcano Pioneer Plus Re-Entry Catheter
  FDA Device · Class II · 2015-09-09 · Volcano
• Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
  FDA Device · Class II · 2015-07-29 · Volcano
• Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
  FDA Device · Class II · 2015-07-29 · Volcano
• Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
  FDA Device · Class II · 2015-07-29 · Volcano
• Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
  FDA Device · Class II · 2015-07-29 · Volcano
• Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 s…
  FDA Device · Class II · 2015-07-29 · Volcano
• Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
  FDA Device · Class II · 2015-07-29 · Volcano
• ComboMap Intravascular Flow and Pressure System
  FDA Device · Class II · 2015-07-15 · Volcano
• Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System
  FDA Device · Class II · 2015-07-15 · Volcano
• Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System
  FDA Device · Class II · 2015-07-15 · Volcano
• Prestige Plus 185cm J-Tip: Part number: 9185J
  FDA Device · Class II · 2015-07-01 · Volcano
• Volcano PV .035 Catheter: Part number: 88901
  FDA Device · Class II · 2015-07-01 · Volcano
• Volcano TrakBack II Disposable Pullback Device
  FDA Device · Class II · 2014-09-24 · Volcano
• Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.0…
  FDA Device · Class II · 2012-09-19 · Volcano