CLASS II Device recall · Reported 15 Jul 2015 · FDA Enforcement Report

ComboMap Intravascular Flow and Pressure System recalled by Volcano

Volcano is recalling ComboMap Intravascular Flow 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

Lot, batch or date codesProduct/Part numbers: Combo Map - 802745-001. All software versions

Quantity recalled227 total units - all models

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-2045-2015
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

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.

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.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Product/Part numbers: Combo Map - 802745-001. 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

This product is part of a recall event; the main page for the event is s5/s5x/CORE Mobile Intravascular Ultrasound Imaging recalled by Volcano.

Reported	Class	Recall	Company	Reason	Where
15 Jul 2015	CLASS II	s5/s5x/CORE Mobile Intravascular Ultrasound Imaging recalled by Volcano	Volcano	Other	Nationwide
15 Jul 2015	CLASS II	s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging recalled by Volcano	Volcano	Other	Nationwide

More recalls from Volcano

All 32

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7 Oct 2026Device	CLASS II	Philips IntraSight Plus recalled by Volcano	Volcano	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS II	Visions Digital IVUS Catheter: PV.014P (Platinum) recalled by Volcano	Volcano	Other	Nationwide
6 Jul 2022Device	CLASS III	Visions PV. 035 Digital IVUS Catheter recalled by Volcano	Volcano	Other	Nationwide
6 Jul 2022Device	CLASS III	Visions PV. 035 Digital IVUS Catheter recalled by Volcano	Volcano	Other	Nationwide
22 Jun 2022Device	CLASS II	Philips OmniWire Pressure guide wire recalled by Volcano	Volcano	Sterility	WA, WI

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7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide