Volcano Corporation recalls
Every recall we track for Volcano Corporation — 6 in all, from 2017–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Volcano Corporation peaked in 2018 (4); 6 since 2017.
All FDA recall records for Volcano Corporation 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 | 1 | 0 | 1 |
| 2018 | 0 | 2 | 1 | 1 | 4 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Volcano Corporation 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 Corporation recalls
5 shown- Lower riskMedical device
Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Volcano recalls SyncVision Systems with software version 4.2.x due to potential incorrect iFR/FFR co-registration results, which could lead to inappropriate patient treatment. Affected units have specific serial numbers and software versions.
VolcanoJan 19, 2022 - UnratedMedical device
Volcano Corporation recalls Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper
Philips Volcano FFR software used in specific imaging systems connected to Hemodynamic Systems may cause interoperability issues. Affected units include Volcano s5i, s5ix, and CORE Mobile Imaging Systems with certain part numbers. No remedy is stated in the recall notice.
Volcano CorporationNov 7, 2018 - Use cautionMedical device
Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035
Volcano Corporation recalls PV .035 Digital IVUS Catheters (catalog 88901) due to potential guidewire failure at y-port. Affected units include specific batch numbers for cardiac imaging procedures.
VolcanoOct 17, 2018 - Lower riskMedical device
Volcano Corporation recalls Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative
Philips Volcano CORE M2 Vascular System (Part #400-0100.17) with specific serial numbers recalled due to incorrect resistor causing overly bright IVUS images. Affected units may show inaccurate vascular imaging results.
VolcanoMar 22, 2018 - Lower riskMedical device
Volcano Corporation recalls Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System
Volcano Corporation 121020083482
Volcano CorporationNov 3, 2017
Volcano Corporation recall questions
How many recalls has Volcano Corporation had?
6 recalls from Volcano Corporation are on record with U.S. safety agencies, from 2017–2022.
What is the most recent Volcano Corporation recall?
Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x, dated Jan 19, 2022. Every Volcano Corporation recall is listed on this page, newest first.
What should I do if I have a recalled Volcano Corporation 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 Corporation 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.