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.
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: 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
- Hazard
- missing-contraindications
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.
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