Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1301-2022·Announced 2022-07-06

IVUS Catheter Recall: Missing Contraindications in Instructions

Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.

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: FDA Class III recall involving significant labeling deficiency (missing contraindications information). No illnesses or injuries reported. The hazard is documentation-related rather than a product defect.

Plain-English summary

Volcano Corp is recalling the Visions PV. 035 Digital IVUS Catheter (Reference 88901, Part Number 300005384002) because the instructions for use (IFU) do not contain contraindications information. Contraindications specify clinical situations in which a device should not be used.

The recall affects approximately 14,031 units distributed worldwide, including throughout the United States and internationally to Spain, Sweden, France, Italy, Germany, Canada, New Zealand, Poland, Brazil, South Africa, Netherlands, and other countries. All lots containing IFU Part Number 300004856772/A with Revision Date 05/2021 are affected.

Healthcare providers using or considering use of this device should contact Volcano Corp for complete safety information, including contraindications, before patient use. Physicians who have already used affected devices should obtain updated instructions for use from the manufacturer.

The recalled product

Product: Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Manufacturer: Volcano Corp
Category: Medical Device — Cardiovascular / IVUS Catheter
Hazard: missing-contraindications
labeling-deficiency

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: 00845225002329

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 →

Severe
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
Digital IVUS Catheter Recalled for Missing Contraindication Information
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