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Health Sciences Authority
Dear Healthcare Professional Letters

Recall of the IN.PACT® AMPHIRION Paclitaxel-eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (IN. PACT Amphirion Drug- Eluting Balloon)

Audiences

Healthcare professional

Product type

Medical devices

19 November 2013

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Medtronic International, Ltd. (Medtronic) would like to inform healthcare professionals of a Medical Device Recall of the IN.PACT® Amphirion Paclitaxel-eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter. Medtronic is initiating a recall based on data from the IN.PACT® DEEP clinical study of below-the-knee revascularization in patients with critical limb ischemia (CLI). The IN.PACT® Amphirion Paclitaxel-eluting PTA Balloon Catheter did not meet its safety and efficacy endpoints relative to the standard PTA control arm, in which a standard PTA balloon catheter was used. The study also identified a potential safety signal showing a trend towards an increased rate of major amputations in the IN.PACT® Amphirion Paclitaxel-eluting PTA Balloon Catheter investigation arm. Medtronic has advised healthcare professionals to remove and quarantine all units that remain in inventory, and return them to Medtronic. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for more details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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