Volcano Corporation
Rancho Cordova, CA
This page shows every FDA and USDA recall linked to Volcano Corporation. 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.
27
Total Recalls
2007
First Recall
2022
Most Recent
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Jan 19, 2022
· Device
Open, Classified
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Phil...
Dec 12, 2019
· Device
Terminated
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272
Product Usage:
The Volca...
Oct 17, 2018
· Device
Terminated
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173
Product Usage:
The Volca...
Oct 17, 2018
· Device
Terminated
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only.
Used for the qualitative and quantitati...
May 17, 2018
· Device
Terminated
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imagi...
Nov 3, 2017
· Device
Terminated
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter;
Product number: 400-0200.273; Catalog...
Apr 10, 2017
· Device
Terminated
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter;
Product number: 400-0200.289; Catalog number 898...
Apr 10, 2017
· Device
Terminated
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits.
Cardiology: T...
Apr 25, 2016
· Device
Terminated
Volcano SpinVision Sterile Equip cover II; Sterile;
General Hospital: These Sterile Equipment covers are prov...
Mar 3, 2016
· Device
Terminated
Volcano R100 Sterile Equipment Cover; Sterile;
General Hospital: These Sterile Equipment covers are provided...
Mar 3, 2016
· Device
Terminated
Volcano Pioneer Plus Re-Entry Catheter;
Product Code PPLUS20, Catheter for Crossing Total Occlusions.
Cardiov...
Sep 2, 2015
· Device
Terminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout...
Jul 20, 2015
· Device
Terminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout...
Jul 20, 2015
· Device
Terminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout...
Jul 20, 2015
· Device
Terminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout...
Jul 20, 2015
· Device
Terminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR...
Jul 20, 2015
· Device
Terminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout...
Jul 20, 2015
· Device
Terminated
Volcano PV .035 Catheter:
Part number: 88901;
Product Usage: The Volcano PV .035 is indicated for use in the...
Jun 25, 2015
· Device
Terminated
Prestige Plus 185cm J-Tip:
Part number: 9185J;
Product Usage: The Prestige Plus Wire is indicated for use to...
Jun 25, 2015
· Device
Terminated
Volcano TrakBack II Disposable Pullback Device;
Sterile and nonpyrogenic; Single Use.
TrakBack II is used to...
Sep 12, 2014
· Device
Terminated
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Num...
Sep 10, 2012
· Device
Terminated
Volcano pcFM Software Kit ;
Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624....
Feb 7, 2012
· Device
Terminated
FloWire Doppler Guide wires.
Volcano Corporation,
Rancho Cardova, Ca.
The Volcano FloWire Doppler guide wire...
Feb 1, 2012
· Device
Terminated
Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 3...
Nov 23, 2010
· Device
Terminated
Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo...
Nov 1, 2010
· Device
Terminated
Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control consol...
Aug 23, 2007
· Device
Terminated