The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0726-2019·Announced 2019-01-23

Volcano Visions PV .035 Digital IVUS Catheter Recall for Guidewire Issue

Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text describes a functional defect (inability to pass guidewire) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters, catalog number 88901, due to a potential inability to pass the guidewire through the y-port of the catheter. The affected devices are over-the-wire imaging catheters with a digital ultrasound transducer on the distal tip, used to generate real-time images of peripheral vessels. The devices are provided sterile and are single-use disposable.

The recall involves 6,870 units distributed worldwide. The specific batch numbers affected are listed in the agency's structured product information. This recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and facilities should stop using the affected catheters and contact Volcano Corporation for further instructions on the recall.

The recalled product

Product
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…
Manufacturer
Volcano Corporation
Category
Medical Device — Cardiovascular / Imaging
Hazard
Affected units
6,870

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Volcano Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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