Volcano recalls

Volcano has 32 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 7 Oct 2026. 7 are still ongoing. 1 was reported in the last 12 months.

Total recalls32since 2012

Last 12 months1reported

Class I00% of total

Ongoing7latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 1Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 1

Severity split

Class I 0 0%Class II 28 88%Class III 4 13%

Why volcano is recalled

Product types

By year

202613%
202513%
2022619%
201939%
201813%
201739%
201639%
20151238%
201413%
201213%

Ongoing volcano recalls

7 active

Reported	Class	Recall	Company	Reason	Where
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
20 Apr 2022Device	CLASS III	Mm-tsm (Touch Screen Module/Secondary Controller/Bedside recalled	Volcano	Foreign Material	50 states
20 Apr 2022Device	CLASS III	IntraSight Mobile IVUS Systems recalled by Volcano	Volcano	Other	15 states

All volcano recalls, newest first

32 total

Reported	Class	Recall	Company	Reason	Where
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
20 Apr 2022Device	CLASS III	Mm-tsm (Touch Screen Module/Secondary Controller/Bedside recalled	Volcano	Foreign Material	50 states
20 Apr 2022Device	CLASS III	IntraSight Mobile IVUS Systems recalled by Volcano	Volcano	Other	15 states
13 Apr 2022Device	CLASS II	SyncVision Systems recalled by Volcano	Volcano	Device Malfunction	46 states
18 Dec 2019Device	CLASS II	Philips Volcano FFR recalled	Volcano	Device Malfunction	Nationwide
23 Jan 2019Device	CLASS II	Visions PV .035 Digital IVUS Catheter recalled by Volcano	Volcano	Other	CA
23 Jan 2019Device	CLASS II	Visions PV .035 Digital IVUS Catheter recalled by Volcano	Volcano	Other	CA
23 May 2018Device	CLASS II	Philips Volcano CORE M2 Vascular System, Part # recalled	Volcano	Other	6 states
6 Dec 2017Device	CLASS II	Imaging System s5i recalled by Volcano	Volcano	Other	Nationwide
19 Apr 2017Device	CLASS II	Refinity Rotational Intravascular Ultrasound (IVUS) Catheter recalled	Volcano	Other	CA
19 Apr 2017Device	CLASS II	Refinity Short Tip Rotational Intravascular Ultrasound recalled	Volcano	Other	CA
1 Jun 2016Device	CLASS II	s5, s5i, Core and Core Mobile systems recalled by Volcano	Volcano	Device Malfunction	Nationwide
9 Mar 2016Device	CLASS II	SpinVision Sterile Equip cover II recalled by Volcano	Volcano	Sterility	Nationwide
9 Mar 2016Device	CLASS II	R100 Sterile Equipment Cover recalled by Volcano	Volcano	Sterility	Nationwide
9 Sep 2015Device	CLASS II	Pioneer Plus Re-Entry Catheter recalled by Volcano	Volcano	Device Malfunction	Nationwide
29 Jul 2015Device	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015Device	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015Device	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015Device	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015Device	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
29 Jul 2015Device	CLASS II	s5/s5i/CORE Intravascular Ultrasound Systems recalled by Volcano	Volcano	Labeling Errors	Nationwide
15 Jul 2015Device	CLASS II	ComboMap Intravascular Flow and Pressure System recalled by Volcano	Volcano	Other	Nationwide
15 Jul 2015Device	CLASS II	s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging recalled by Volcano	Volcano	Other	Nationwide
15 Jul 2015Device	CLASS II	s5/s5x/CORE Mobile Intravascular Ultrasound Imaging recalled by Volcano	Volcano	Other	Nationwide
1 Jul 2015Device	CLASS II	PV .035 Catheter recalled by Volcano	Volcano	Other	Nationwide
1 Jul 2015Device	CLASS II	Prestige Plus J-Tip recalled by Volcano	Volcano	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.