CLASS III ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

IntraSight Mobile IVUS Systems recalled by Volcano

Volcano is recalling IntraSight Mobile IVUS Systems, distributed in 15 states. The recall was initiated on 24 Jan 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesAll MM-TSM units, Device Identifier (DI): 00845225012915

Quantity recalled47

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-0901-2022
FDA event ID: 89677
Recalling firm: Volcano, San Diego, CA
Classification: Class III
Status: Ongoing
Recall initiated: 24 Jan 2022
FDA classified: 8 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Jan 2022	Recall initiated by company
8 Apr 2022	Classified by FDA	+74 days
20 Apr 2022	Published in enforcement report	+12 days

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

Reason for recall

Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.

Product as listed by the FDA

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

Where it was distributed

US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT

Arizona California Colorado Delaware Florida Georgia Massachusetts Maryland Missouri North Carolina New York Oregon Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

All MM-TSM units, Device Identifier (DI): 00845225012915

Where was it sold?

US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

More recalls from Volcano

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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

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