CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report

s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano

Volcano is recalling s5/s5i/CORE Intravascular Ultrasound Systems, distributed nationwide in the US. The recall was initiated on 22 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel s5i. Part number: 806300-020.

Quantity recalledA total of 4007 devices, 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-2134-2015
FDA event ID: 71654
Recalling firm: Volcano, Rancho Cordova, CA
Classification: Class II
Status: Terminated
Recall initiated: 22 Jun 2015
FDA classified: 20 Jul 2015
Reported: 29 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

22 Jun 2015	Recall initiated by company
20 Jul 2015	Classified by FDA	+28 days
29 Jul 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Product as listed by the FDA

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Where it was distributed

Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina

Nationwide

Questions about this recall

Why was it recalled?

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Which lots are affected?

Model s5i. Part number: 806300-020.

Where was it sold?

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

5 other products · FDA event 71654

This product is part of a recall event; the main page for the event is s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano.

Reported	Class	Recall	Company	Reason	Where
29 Jul 2015	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide

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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
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