Recall for the TRUE Dilatation™ Balloon Valvuloplasty Catheters, Loma Vista Medical
2013.04.26
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01512/13
The Loma Vista Medical, Inc. recalls TRUE Dilatation™ Balloon Valvuloplasty Catheters from the market. Due to a twisting imparted on the balloon during the manufacturing process the device performance specification for deflation time may exceed the 10 seconds maximum.