CLASS II Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
s5/s5x/CORE Mobile Intravascular Ultrasound Imaging recalled by Volcano
Volcano is recalling s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System, distributed nationwide in the US. The recall was initiated on 23 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2043-2015
- FDA event ID
- 71404
- Recalling firm
- Volcano, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2013
- FDA classified
- 8 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 23 Sep 2013 | Recall initiated by company | |
| 8 Jul 2015 | Classified by FDA | +653 days |
| 15 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Product as listed by the FDA
Volcano 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.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
Questions about this recall
Why was it recalled?
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Which lots are affected?
s5 Part number 804200-002 and 804200-014; s5x Part number 807300-001; CORE MOBILE Part Number 400-0100.01. All software versions
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 71404| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging recalled by Volcano | Volcano | Other | Nationwide | |
| CLASS II | ComboMap Intravascular Flow and Pressure System recalled by Volcano | Volcano | Other | Nationwide |
More recalls from Volcano
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips IntraSight Plus recalled by Volcano | Volcano | Device Malfunction | Nationwide |
| Device | CLASS II | Visions Digital IVUS Catheter: PV.014P (Platinum) recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS III | Visions PV. 035 Digital IVUS Catheter recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS III | Visions PV. 035 Digital IVUS Catheter recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS II | Philips OmniWire Pressure guide wire recalled by Volcano | Volcano | Sterility | WA, WI |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |