Volcano Corp recalls specific digital IVUS catheters due to missing contraindications in instructions. Affected units have IFU part number 300004856772/A with revision date 05/2021. Consumers should check their catheter labels for the UDI/DI code 00845225002329.
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Volcano Corp is recalling certain digital IVUS catheters because their instructions for use do not include contraindications. This means users might not be aware of conditions where the catheter should not be used, potentially leading to unsafe medical procedures.
The catheter's instructions for use lack information about medical conditions where the device should not be used. This could lead to inappropriate application in certain patient cases, but the risk is not immediate or life-threatening under normal medical use.
Healthcare professionals using the Volcano Visions PV.035 Digital IVUS Catheter for medical procedures are most at risk. Patients receiving the catheter under a doctor's supervision may also be affected if the instructions are incomplete.
Check the catheter's label for the IFU part number 300004856772/A with a revision date of 05/2021. The unique device identifier (UDI/DI) should be 00845225002329.
Look for the IFU part number 300004856772/A with revision date 05/2021 and UDI/DI code 00845225002329.
The recall is because the instructions for use do not contain contraindications, which could lead to unsafe medical procedures in certain patient cases.
Check the label for IFU part number 300004856772/A with revision date 05/2021 and UDI/DI code 00845225002329.
No, the recall does not require stopping use immediately. However, healthcare professionals should verify the catheter's label to confirm it is affected.
We’ve drafted a message you can send Volcano Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-1301-2022 — Volcano Corp Volcano Corp Hello, I own a Volcano Corp that is covered by recall Z-1301-2022 from Volcano Corp. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
