Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Extractor Pro RX-S. The affected devices are identified as follows:
The manufacturer is implementing a voluntary Medical Device Removal on two lots of Extractor Pro RX-S Retrieval Balloon Catheters. The labeling on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon.
If the injection location is above or below where labeled, then the user will see contrast emerge from the other location, but still within the lumen. This may result in a minor procedure delay due to the need for device exchange.
The manufacturer advises users to identify, segregate and return the affected product to the manufacturer.
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 June 2017