Volcano Corp recalls specific digital IVUS catheters due to missing contraindications in instructions. Affected units have a unique part number and revision date. Consumers should check their product details to determine if they are affected.
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 device should not be used, potentially leading to unsafe medical procedures.
The catheter's instructions for use lack information about conditions where the device should not be used. This omission could lead to unsafe medical procedures if healthcare providers proceed without knowing contraindications.
Healthcare professionals using the Volcano Visions PV.035 Digital IVUS Catheter for medical procedures are most at risk. Patients receiving this device during procedures may also be affected if the instructions are incomplete.
Check for the part number 300004856772/A with a revision date of 05/2021 on the device's instructions. The unique identifier (UDI/DI) 00845225002596 is also associated with this specific recall.
Review the instructions for use to confirm the part number 300004856772/A and revision date 05/2021.
The recall is due to the instructions for use not containing contraindications, which could lead to unsafe medical procedures.
Check for the part number 300004856772/A with revision date 05/2021 on the instructions or the unique identifier 00845225002596.
The recall record does not specify a remedy, so contact Volcano Corp directly for guidance.
We’ve drafted a message you can send Volcano Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-1302-2022 — Volcano Corp Volcano Corp Hello, I own a Volcano Corp that is covered by recall Z-1302-2022 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.
