Volcano Visions PV .035 Digital IVUS Catheter Recalled for Guidewire Issue
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.
What this means for you
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a mechanical defect (inability to pass guidewire) without reported injuries or deaths, fitting the Moderate severity criteria for a functional defect in a medical device.
Plain-English summary
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters (catalog numbers 88901 and 81234) 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 1,240 units that were distributed worldwide. The specific hazard identified is a mechanical issue where the guidewire cannot be passed through the y-port of the catheter. This defect may prevent the proper use of the device during medical procedures.
Healthcare providers and facilities should check their inventory for the affected catalog numbers and batch numbers listed in the recall notice. If the device is found, it should be removed from service and returned to Volcano Corporation or the distributor as directed by the company.
The recalled product
- Product
- 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 cyli
- Manufacturer
- Volcano Corporation
- Affected units
- 1,240
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.
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