| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01153-1 |
| Product Name/Description |
IN.PACT Amphirion Drug-Eluting Balloon (DEB) (used for percutaneous transluminal angioplasty of small peripheral arteries)
Supplied in Australia under the Special Access Scheme (SAS) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Based on data from clinical study, the IN.PACT Amphirion drug-eluting balloon (DEB) did not meet its safety and efficacy endpoints relative to the percutaneous transluminal angioplasty (PTA) control. The study also identified a potential safety signal given a trend towards an increased rate of major amputations in the DEB study arm. Causality between major amputation and use of the IN.PACT Amphirion DEB could not be established or excluded. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising hospitals to quarantine all units of the IN.PACT Amphirion DEB that remain in their inventory. |
| Contact Information |
1800 668 670 - Medtronic Australasia |