AngioScore Incorporated Announces Worldwide Voluntary Field Removal of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018
Posted Jan 09 2011 10:36am
FOR IMMEDIATE RELEASE - On November 15, 2010 - AngioScore Incorporated, Fremont, CA initiated a worldwide recall of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018” OTW, balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm. This recall was initiated because of a small number of reports from the field of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element, wherein the proximal end of the scoring element remains secured to the catheter. Retained device fragments or significant arterial injury due to device failure may occur which may lead to death, need for percutaneous catheter-based interventions to remove retained device fragments, increased exposure to anesthesia, and loss of limb. There have been no reported injuries related to this failure mode to date.
The company estimates that 14,775 affected products have been distributed in the United States and 2,907 affected products have been distributed outside the United States. FDA has classified this action as a Class I recall, meaning that FDA believes the use of this product may cause serious adverse health consequences or death.
This voluntary recall does not affect the AngioSculpt PTCA catheters, or any AngioSculpt PTA catheter balloon sizes (in millimeters): 0.014” OTW, 2.0x10, 2.0x20, 2.5x20, 3.0x20, 3.5x20; and 0.018”OTW, 4.0x40, 5.0x40, 6.0x40.
The recall includes the following model numbers and lot numbers: