Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15634 |
| Brand Name: | Medtronic IN.Pact Amphirion Drug-Eluting Balloon (DEB) |
| Model: | |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Invatec Technology Centre GmBH |
| Issue: | Based on data from the IN.PACT DEEP clinical study manufacturer has decided to recall and stop supplying the IN.PACT Ampirion drug-eluting balloon as it did not meet its safety and efficacy end points 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. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/11/2013 |
