Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16348
Brand Name:Covidien Stellarex Paclitaxel-Coated Angioplasty Balloon Catheter
Model:All devices
Affected:All lots
Software version:
Recalling Organisation:Covidien NZ Ltd
Level 3, Building 5, Central Park Corporate Centre
666 Great South Road
Penrose
AUCKLAND 1051
Contact Information:0508 489 264
Manufacturer:Covidien Inc
Issue:The manufacturer has identified a low rate of potential damage to the product sterile barrier during final packaging, resulting in the possibility of loss of sterility.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:5/3/2014
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