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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 Medtronic Australasia Pty Ltd
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