Volcano recalls
7 official recalls and safety alerts involving Volcano since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Volcano or the relevant agency.
- 2026-10-07
USVolcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
FDA · DeviceVolcano CorpWorldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA…Official notice →- 2025-08-06
- US
Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with…
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as…
FDA · DeviceVolcano CorpWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - 2022-07-06
- US
Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
FDA · DeviceVolcano CorpWorldwide distribution - US Nationwide distribution in the states of NY, CA,…Official notice → - 2022-06-22
- US
Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Due to a potential failed sterilization process.
- 2022-04-20
- US
Volcano Corp recalls MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight…
Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will…
FDA · DeviceVolcano CorpUS: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO,…Official notice → - US
Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer…
FDA · DeviceVolcano CorpUS: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB,…Official notice → - 2022-04-13
- US
Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to…
FDA · DeviceVolcano CorporationUS: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX,…Official notice →