Volcano Corporation recalls

20 recalls on record · latest: January 19, 2022

Official U.S. recall history for Volcano Corporation, compiled from official government records.

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Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

January 19, 2022 · Medical device recalls Moderate risk If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in…

Volcano Corporation recalls Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper…

November 7, 2018 · Medical device recalls Moderate risk Interoperability issue that affects certain systems that use the recalled softw…

Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035…

October 17, 2018 · Medical device recalls Moderate risk Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901…

Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035…

October 17, 2018 · Medical device recalls Moderate risk Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901…

Volcano Corporation recalls Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluat…

March 22, 2018 · Medical device recalls Moderate risk The incorrect resistor has been used in affected CORE M2 Imaging Systems, which…

Volcano Corporation recalls Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System…

November 3, 2017 · Medical device recalls Moderate risk On certain Impacted Systems, an unexpected Microsoft Windows Security dialog ma…

Volcano Corporation recalls Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89…

March 29, 2017 · Medical device recalls Moderate risk High complaint rates of kinking near the junction of the proximal shaft to tele…

Volcano Corporation recalls Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardi…

March 29, 2017 · Medical device recalls Moderate risk High complaint rates of kinking near the junction of the proximal shaft to tele…

Volcano Corporation recalls Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano…

April 25, 2016 · Medical device recalls Moderate risk Volcano has become aware of an incompatibility issue between Impacted Systems a…

Volcano Corporation recalls Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover e…

February 5, 2016 · Medical device recalls Moderate risk Volcano Corporation has identified that certain lot numbers of Volcano R-100 St…

Volcano Corporation recalls Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to co…

February 5, 2016 · Medical device recalls Moderate risk Volcano Corporation has identified that certain lot numbers of Volcano R-100 St…

Volcano Corporation recalls Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: T…

July 22, 2015 · Medical device recalls Moderate risk Due to a manufacturing defect, there is the possibility that a small wire could…

Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolo…

June 22, 2015 · Medical device recalls Moderate risk A software issue was discovered where an inaccurate FFR/iFR value could be calc…

Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolo…

June 22, 2015 · Medical device recalls Moderate risk A software issue was discovered where an inaccurate FFR/iFR value could be calc…

Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Tec…

June 22, 2015 · Medical device recalls Moderate risk A software issue was discovered where an inaccurate FFR/iFR value could be calc…

Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolo…

June 22, 2015 · Medical device recalls Moderate risk A software issue was discovered where an inaccurate FFR/iFR value could be calc…

Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolo…

June 22, 2015 · Medical device recalls Moderate risk A software issue was discovered where an inaccurate FFR/iFR value could be calc…

Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolo…

June 22, 2015 · Medical device recalls Moderate risk A software issue was discovered where an inaccurate FFR/iFR value could be calc…

Volcano Corporation recalls Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pr…

June 4, 2015 · Medical device recalls Moderate risk During a relabeling procedure at the manufacturing facility, the products were…

Volcano Corporation recalls Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation…

June 4, 2015 · Medical device recalls Moderate risk During a relabeling procedure at the manufacturing facility, the products were…