Volcano Corp

Complete recall history across all FDA and CPSC categories — 9 total recalls

Volcano Corp 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 (9)

FDA medical device enforcement actions by Volcano Corp

Date Product Reason Class
Jun 13, 2025 Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.01... Reports of IVUS catheter and guide wire entanglement during radial-to-periphe... Class II
May 16, 2022 Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 Due to a potential failed sterilization process. Class II
May 13, 2022 Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , R... Digital IVUS catheter instructions for use ( IFU) do not contain contrainidi... Class III
May 13, 2022 Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx ... Digital IVUS catheter instructions for use ( IFU) do not contain contrainidi... Class III
Feb 3, 2022 MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Nu... Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS syste... Class III
Jan 24, 2022 IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30... Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary con... Class III
Sep 23, 2013 ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo... A limitation in interoperability between the Philips Xper Flex Cardia Physiom... Class II
Sep 23, 2013 Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure Sys... A limitation in interoperability between the Philips Xper Flex Cardia Physiom... Class II
Sep 23, 2013 Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure Syst... A limitation in interoperability between the Philips Xper Flex Cardia Physiom... 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.

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