FDA Device recall Z-2045-2015
ComboMap Intravascular Flow and Pressure System
- FDA Device
- Class II
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class II recall of ComboMap Intravascular Flow and Pressure System by Volcano, citing 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 calcu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2045-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-23 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volcano |
| Distribution | US |
Product
ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Reason
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.
Identifiers
| code_info | Product/Part numbers: Combo Map - 802745-001. All software versions |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2045-2015%22
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