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.
What this means for you
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
- 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.
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