Recall of the Stonetome™ Single-Use Stone Removal Device from Boston Scientific
2006.06.13
Product group Optics / Precision engineering
Reference 01543/06
Boston Scientific recalls specific lots of the Stonetome™ Single-Use Stone Removal Device (lots and catalogue numbers see annex). Internal tests revealed failures in the packaging that potentially result in a breach of the sterile barrier. The sterility of the products is not guaranteed, incidents have not been reported. The Stonetome™ device is a biliary catheter including a sphincterotome and a balloon.