Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1302-2022·Announced 2022-07-06

Digital IVUS Catheter Recalled for Missing Contraindication Information

Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving missing contraindication information in device labeling. No injuries or illnesses have been reported. The issue is a documentation deficiency rather than a device malfunction, placing this in the Moderate category per the severity rubric.

Plain-English summary

Volcano Corp has issued a recall of 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter (intravenous ultrasound catheter). The recall affects units distributed worldwide, including across all US states.

The recall was initiated because the instructions for use (IFU) do not contain contraindication information. Contraindications specify medical situations or conditions in which the device should not be used, and their omission means healthcare providers may lack critical guidance on proper device application.

Affected units are identified by IFU Part Number 300004856772/A with Revision Date 05/2021. Healthcare providers who have received this device should review their copies of the instructions and contact Volcano Corp for updated IFU documentation that includes the missing contraindication information.

Patients currently using or scheduled to use this device should speak with their healthcare provider to ensure they understand any conditions under which the device may not be appropriate for their situation.

The recalled product

Product: Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Manufacturer: Volcano Corp
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: missing-contraindications
Affected units: 7,520

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 (2)

All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021
UDI/DI: 00845225002596

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

Same manufacturer · Volcano Corp

See all →

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Volcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
High
Volcano Visions IVUS catheters can entangle with the guide wire
FDA (Devices) · 2025-08-06
Moderate
IVUS Catheter Recall: Missing Contraindications in Instructions
FDA (Devices) · 2022-07-06
High
Philips OmniWire guide wire recalled for potential sterilization failure
FDA (Devices) · 2022-06-22
Low
IntraSight Mobile IVUS touch screen modules missing required labeling information
FDA (Devices) · 2022-04-20

Same hazard · missing contraindications