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: 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

Quantity recalled6870 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-0726-2019
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 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.

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: 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

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

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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7 Oct 2026Device	CLASS II	Philips IntraSight Plus recalled by Volcano	Volcano	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS II	Visions Digital IVUS Catheter: PV.014P (Platinum) recalled by Volcano	Volcano	Other	Nationwide
6 Jul 2022Device	CLASS III	Visions PV. 035 Digital IVUS Catheter recalled by Volcano	Volcano	Other	Nationwide
6 Jul 2022Device	CLASS III	Visions PV. 035 Digital IVUS Catheter recalled by Volcano	Volcano	Other	Nationwide
22 Jun 2022Device	CLASS II	Philips OmniWire Pressure guide wire recalled by Volcano	Volcano	Sterility	WA, WI

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