Brand

Volcano Corporation Recalls

13 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Volcano Corporation.

13Total Recalls
0Critical
39,471Units Affected
Jan 19, 2022Most Recent
All Recalls

Every Volcano Corporation Recall

Sorted by most recent. Click any recall for full details.

13 recalls
High RiskFDA
Volcano Corporation
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Medical Devices·3,216 affected·Jan 19, 2022
High RiskFDA
Volcano Corporation
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular...
Medical Devices·8 affected·Mar 22, 2018
High RiskFDA
Volcano Corporation
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 4...
Medical Devices·1,166 affected·Nov 3, 2017
High RiskFDA
Volcano Corporation
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Cor...
Medical Devices·5,875 affected·Apr 25, 2016
High RiskFDA
Volcano Corporation
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that i...
Surgical Devices·1,355 affected·Feb 5, 2016
High RiskFDA
Volcano Corporation
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment t...
Surgical Devices·1,355 affected·Feb 5, 2016
High RiskFDA
Volcano Corporation
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pio...
Surgical Devices·5,042 affected·Jul 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
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...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blo...
Diagnostic Devices·162 affected·Jun 4, 2015
High RiskFDA
Volcano Corporation
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter stead...
Surgical Devices·8,251 affected·Aug 13, 2014
High RiskFDA
Volcano Corporation
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...
Medical Devices·1,020 affected·Aug 24, 2012