Recall of the IN.PACT® Amphirion Drug-Eluting Balloon (DEB), Medtronic
2013.11.28
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06771/13
The Medtronic, Inc. recalls all IN.PACT® Amphirion Drug-Eluting Balloons (DEB) from the market. In a study, the IN.PACT Amphirion DEB did not meet its safety and efficacy endpoints relative to the percutaneous transluminal angioplasty (PTA) control. The study identified a potential safety signal given a trend towards an increased rate of major amputations in the DEB study arm.