AngioScore has initiated a worldwide recall of the AngioSculpt PTA Scoring Balloon Catheter, 0.018-inch OTW, balloon sizes: 4x20 mm, 5x20 mm and 6x20 mm. The recall was initiated because of a “small number of reports” of distal bond failure, which has resulted in the 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.
According to AngioScore, retained device fragments or 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 Fremont, Calif.-based company estimates that 14,775 affected products have been distributed in the U.S. and 2,907 affected products have been distributed outside the U.S. The FDA has classified this action as a Class I recall, because the use of this product may cause serious adverse health consequences or death.
The recall includes the following model numbers and lot numbers:
Part (REF) Number
|Product Description||Lot Numbers|
|2076-4020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018-inch Platform, 137 cm, 4x20 mm balloon size||All|
|2076-5020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018-inch Platform, 137 cm, 5x20 mm balloon size||All|
|2076-6020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018-inch Platform, 137 cm, 6x20 mm balloon size||All|
|2092-6020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018-inch Platform, 90 cm, 6x20 mm balloon size||All|
|2105-6020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018-inch Platform, 50 cm, 6x20 mm balloon size||All|
The company said this recall does not affect the AngioSculpt PTCA catheters, or any AngioSculpt PTA catheter balloon sizes (in millimeters): 0.014-inch OTW, 2x10, 2x2, 2.5x20, 3x20, 3.5x20; and 0.018-inch OTW, 4x40, 5x40, 6x40.
AngioScore has notified the hospitals that have received the recalled product and has instructed these hospitals to cease the use of affected product and return the affected product to AngioScore.