Volcano ComboMap Intravascular System Recalled for Interoperability Limitation
Volcano Corp is recalling 227 ComboMap Intravascular Flow and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia Physiomonitoring System.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a technical limitation may impact the calculation of a critical diagnostic metric (FFR). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class II.
Plain-English summary
Volcano Corp is recalling 227 units of the ComboMap Intravascular Flow and Pressure System (Product/Part number: Combo Map - 802745-001). The recall affects all software versions and includes units distributed worldwide, including the United States, Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines, and Thailand.
The recall is due to 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.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- 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.
- Manufacturer
- Volcano Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 227
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product/Part numbers: Combo Map - 802745-001. All software versions
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Volcano Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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