Volcano Corporation
Complete recall history across all FDA and CPSC categories — 22 total recalls
Volcano Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (22)
FDA medical device enforcement actions by Volcano Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 19, 2022 | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software versi... | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback i... | Class II |
| Nov 7, 2018 | Philips Volcano FFR software used in the following systems connected to the M... | Interoperability issue that affects certain systems that use the recalled sof... | Class II |
| Oct 17, 2018 | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0... | Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 889... | Class II |
| Oct 17, 2018 | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0... | Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 889... | Class II |
| Mar 22, 2018 | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used... | The incorrect resistor has been used in affected CORE M2 Imaging Systems, whi... | Class II |
| Nov 3, 2017 | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) R... | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog ... | Class II |
| Mar 29, 2017 | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number... | High complaint rates of kinking near the junction of the proximal shaft to te... | Class II |
| Mar 29, 2017 | Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Prod... | High complaint rates of kinking near the junction of the proximal shaft to te... | Class II |
| Apr 25, 2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v... | Volcano has become aware of an incompatibility issue between Impacted Systems... | Class II |
| Feb 5, 2016 | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: Thes... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 ... | Class II |
| Feb 5, 2016 | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Ste... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 ... | Class II |
| Jul 22, 2015 | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for C... | Due to a manufacturing defect, there is the possibility that a small wire cou... | Class II |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be ca... | Class II |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be ca... | Class II |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be ca... | Class II |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3... | A software issue was discovered where an inaccurate FFR/iFR value could be ca... | Class II |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be ca... | Class II |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be ca... | Class II |
| Jun 4, 2015 | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano... | During a relabeling procedure at the manufacturing facility, the products wer... | Class II |
| Jun 4, 2015 | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Presti... | During a relabeling procedure at the manufacturing facility, the products wer... | Class II |
| Aug 13, 2014 | Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; S... | Internal testing had identified a potential breach to the sterile barrier tha... | Class II |
| Aug 24, 2012 | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Versio... | The display on the system has the potential to change. In house testing event... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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