Volcano Corp recalls
Every recall we track for Volcano Corp — 7 in all, from 2022–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Volcano Corp peaked in 2022 (5); 7 since 2017.
All FDA recall records for Volcano Corp since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 4 | 1 | 5 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 1 | 0 | 0 | 1 |
| 2026 (to date) | 0 | 1 | 0 | 0 | 1 |
What to do if you have a recalled Volcano Corp product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Volcano Corp recalls
6 shown- Use cautionMedical device
Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Philips IntraSight Plus systems with software version 6.0.4 may link patient records incorrectly, risking wrong diagnoses. Affected units sold worldwide since 2026.
Volcano CorpAug 6, 2026 - Use cautionMedical device
Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700,
Volcano Corp recalls specific IVUS catheter models due to entanglement risks during radial-to-peripheral procedures, requiring proper sheath use to prevent complications.
Volcano CorpJun 13, 2025 - Lower riskMedical device
Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 due to potential failed sterilization. Affected units have specific serial numbers and part numbers.
Volcano CorpMay 16, 2022 - Lower riskMedical device
Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Volcano Corp recalls specific digital IVUS catheters due to missing contraindications in instructions. Affected units have IFU part number 300004856772/A with revision date 05/2021. Consumers should check their catheter labels for the UDI/DI code 00845225002329.
Volcano CorpMay 13, 2022 - Lower riskMedical device
Volcano Corp recalls MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used
Volcano Corp recalls MM-TSM touch screen modules used with IVUS systems that may crack, causing non-functionality. Affected units have specific part numbers and require replacement of protective beams.
Volcano CorpFeb 3, 2022 - Lower riskMedical device
Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Volcano Corp recalls IntraSight Mobile IVUS Systems Model 797415 with missing labeling for safety. Affected units include specific part numbers and device identifiers.
Volcano CorpJan 24, 2022
Volcano Corp recall questions
How many recalls has Volcano Corp had?
7 recalls from Volcano Corp are on record with U.S. safety agencies, from 2022–2026.
What is the most recent Volcano Corp recall?
Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA, dated Aug 6, 2026. Every Volcano Corp recall is listed on this page, newest first.
What should I do if I have a recalled Volcano Corp product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Volcano Corp recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.