Volcano Corporation recalls PV .035 Digital IVUS Catheters (catalog 88901) due to potential guidewire failure at y-port. Affected units include specific batch numbers for cardiac imaging procedures.
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 PV .035 Digital IVUS Catheters because they may not allow guidewires to pass through the y-port during medical procedures. This could lead to complications in cardiac imaging treatments.
The catheter's y-port may not properly allow guidewires to pass through, which is critical for connecting imaging tools during cardiac procedures. This could cause imaging to fail or require additional interventions.
Healthcare professionals using these catheters for cardiac imaging procedures are most at risk. Patients undergoing procedures with the recalled devices could face complications.
Check for the catalog number 88901 or part number 400-0200.173 on the catheter. Affected units include specific batch numbers listed in the recall notice.
Look for the catalog number 88901 or part number 400-0200.173 on the catheter packaging or device.
The catheter may not allow guidewires to pass through the y-port during medical procedures, which could cause imaging failures or complications.
Affected batch numbers include 0301438588, 0301450806, 0301457390, and other specific numbers listed in the recall notice.
The recall does not require immediate stoppage; healthcare professionals should check the batch number and follow the provided steps.
We’ve drafted a message you can send Volcano to request your refund or repair — edit it as you like.
Subject: Recall Z-0726-2019 — Volcano Volcano Hello, I own a Volcano that is covered by recall Z-0726-2019 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.
