Medical device manufacturer, Philips Volcano, has issued a medical device safety alert concerning its Visions PV .035 Intravascular Ultrasound (IVUS) Catheter [Catalog Number: 88901, 81234; Affected Batch Number in Hong Kong: 0301450811, 0301485800, 0301485801; Expiry date: 30 Apr 2020 - 31 Aug 2020].
The manufacturer is providing an advisory notice regarding the affected products due to the potential for inability to pass the guide wire through the y-port of the catheter. The manufacturer has received complaints that approximately 20% of devices in affected lots may demonstrate an inability to insert the guide wire into the catheter. This has caused no known adverse events. The issue has been corrected for Visions PV .035 catheters manufactured after 20 Sep 2018.
According to the manufacturer, it can lead to a delay of case while the defective product is exchanged for another device.
According to the local supplier, the affected products are distributed in Hong Kong. Product replacement is on-going.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 26 Oct 2018