Volcano PV .035 Digital IVUS Catheter Recall: Guidewire May Not Pass Through Y-Port
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/69609-volcano-pv-035-digital-ivus-catheter-recall-guidewire-may-not.
Source Summary by GovInfoNow · govinfonow.com/recall/69609-volcano-pv-035-digital-ivus-catheter-recall-guidewire-may-not · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0726-2019
Cite this page
“Volcano PV .035 Digital IVUS Catheter Recall: Guidewire May Not Pass Through Y-Port.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69609-volcano-pv-035-digital-ivus-catheter-recall-guidewire-may-not. Based on FDA recall #Z-0726-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0726-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Healthcare professionals using these catheters for cardiac imaging procedures are most at risk. Patients undergoing procedures with the recalled devices could face complications.
How to tell if you have this one
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.
- Brand
Volcano- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0726-2019 | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.; Batch Numbers: 0301438588 0301450806 0301457390 0301457394 0301461995 0301487960 0301457393 0301450808 0301435421 0301442654 0301446201 0301469590 0301469593 0301442649 0301446202 0301476726 0301480937 0301485800 0301465886 0301498206 0301420742 0301485801 0301441407 0301469591 0301465885 0301476727 0301450809 0301480927 0301453527 0301440822 0301450812 0301453524 0301461996 0301476725 0301480928 0301492147 0301422648 0301450811 0301461999 0301450810 0301430794 0301430795 0301446203 0301472637 0301430796 0301465887 | 6870 units |
| Z-0727-2019 | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.; Batch Numbers: 0301425755 0301418943 0301424426 0301420226 0301425756 0301425758 0301424427 0301418942 0301425757 0301430789 0301430790 0301430792 0301430791 0301420227 0301431656 0301431657 0301431658 0301438592 0301440863 0301438593 0301441405 0301441406 0301442658 0301446207 0301450813 0301450814 0301453531 0301457395 0301457396 0301457397 0301457398 0301465894 0301462001 0301462002 0301462003 0301465896 0301453530 0301465897 0301469598 0301469597 0301469599 0301453529 0301472646 0301472651 0301476733 0301492152 0301487364 0301487363 0301485883 0301485884 0301487964 0301487965 0301481405 0301492153 0301501411 | 1240 units |
What to do — step by step
Check Product Details
Look for the catalog number 88901 or part number 400-0200.173 on the catheter packaging or device.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this catheter?
The recall does not require immediate stoppage; healthcare professionals should check the batch number and follow the provided steps.
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Where this comes from
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.
- Official source: FDA Recall #Z-0726-2019 (October 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0726-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.