Volcano recalls PV .035 Digital IVUS Catheters (catalog 81234) due to potential guidewire failure at y-port. Affected units include specific batch numbers. Contact for remedy.
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
Volcano Corporation is recalling its PV .035 Digital IVUS Catheters because they may not allow a guidewire to pass through the y-port, which could cause imaging failure during medical procedures. This recall affects specific batch numbers of the catheters used in cardiac procedures.
The catheter's y-port design may prevent guidewires from passing through properly, leading to imaging failure. This could result in inaccurate vessel imaging during critical cardiac procedures, potentially delaying or complicating treatment.
Healthcare professionals using the catheters for cardiac imaging procedures are most at risk. Patients undergoing these procedures may be affected if the catheter fails during use.
Check for the product name 'Visions PV .035 Digital IVUS Catheter' with catalog number 81234. Affected units include specific batch numbers listed in the recall notice.
Identify the batch number on the catheter packaging or label to confirm if it is affected.
Reach out to Volcano Corporation for guidance on next steps if the catheter is affected.
The catheters may not allow a guidewire to pass through the y-port, which could cause imaging failure during cardiac procedures.
Affected batch numbers include 0301425755, 0301418943, 0301424426, and other specific numbers listed in the recall notice.
No immediate stop is required, but affected units should be checked and contacted for guidance.
We’ve drafted a message you can send Volcano to request your refund or repair — edit it as you like.
Subject: Recall Z-0727-2019 — Volcano Volcano Hello, I own a Volcano that is covered by recall Z-0727-2019 from Volcano. 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.
