Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Extractor Pro XL Retrieval Balloon Catheter. The Material numbers (UPN) of the affected products with expiration date of 31 July 2015 are as follows:
The manufacturer is initiating this medical device recall for three lots of the Extractor Pro XL Retrieval Balloon Catheter device. The manufacturer has become aware that these three lots may be labeled with an incorrect balloon size and/ or skive injection location. If the Extractor device is smaller than the included syringe, balloon burst may occur and air may be released or a balloon fragment could be released which could pass naturally through the GI tract or be retrieved. If the Extractor device is larger than the included syringe, the balloon under-inflation may occur, and no injury would be expected. If the skive location is above or below where labeled, then the user will see contrast emerge from the other location but still within the lumen.
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 23 December 2013