CLASS II Device recall · Reported 23 Jan 2019 · FDA Enforcement Report

Visions PV .035 Digital IVUS Catheter recalled by Volcano

Volcano is recalling Visions PV .035 Digital IVUS Catheter. The recall was initiated on 17 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch 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

Quantity recalled1240 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0727-2019
FDA event ID: 81882
Recalling firm: Volcano, Rancho Cordova, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2018
FDA classified: 11 Jan 2019
Reported: 23 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

17 Oct 2018	Recall initiated by company
11 Jan 2019	Classified by FDA	+86 days
23 Jan 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Worldwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 81882

This product is part of a recall event; the main page for the event is Visions PV .035 Digital IVUS Catheter recalled by Volcano.

Reported	Class	Recall	Company	Reason	Where
23 Jan 2019	CLASS II	Visions PV .035 Digital IVUS Catheter recalled by Volcano	Volcano	Other	CA

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