FDA Medical Device Recalls (openFDA)
Volcano Corp: 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.
- Recall number
- Z-2045-2015
- Recalling firm
- Volcano Corp
- 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.
- Status
- Terminated
- Initiated
- 2013-09-23
- Posted
- 2015-07-08
- Terminated
- 2015-07-09
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative.
- Quantity
- 227 total units - all models
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
- Lot, serial or model codes
- Product/Part numbers: Combo Map - 802745-001. All software versions
- 510(k) numbers
- ["K082229"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 3008363989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28