Recall Register

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Volcano Corp

FDA recalling firm · 6 enforcement events · 9 product records · 2013–2025 · CA

Volcano Corp has 6 FDA enforcement events on this register (9 product records) between 2013 and 2025: 6 device; the busiest year was 2022 with 4.

0% of its events are Class I; the most common class is Class II (3). 4 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
13 Jun 2025Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.DeviceClass II1Ongoing
16 May 2022Philips OmniWire Pressure guide wire REF 89185J PN 300000252891DeviceClass II1Terminated
13 May 2022Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797DeviceClass III2Ongoing
3 Feb 2022MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systemsDeviceClass III1Ongoing
24 Jan 2022IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102DeviceClass III1Ongoing
23 Sep 2013Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.DeviceClass II3Terminated

By type and class

Device6
Class II3
Class III3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for Volcano Corp by year initiated.

Questions and answers

How many FDA recalls has Volcano Corp had?

6 enforcement events (9 product records) on this register, 2013–2025: 6 device.

Are any Volcano Corp recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Volcano Corp recalls?

3 Class II, 3 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.