Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19962
Brand Name:Bayer Essure
Model:
Affected:
Software version:
Recalling Organisation:New Zealand Medical & Scientific Ltd
Level 4, Building 10
666 Great South Road
Ellerslie
AUCKLAND 1051
Contact Information:09 259 4062
Manufacturer:Venusa de Mexica SA de CV a Lake Region Medical Company
Issue:Sponsor advised that there is an upcoming revsion of the IFU as women who undergo an Essure procedure and an endometrial ablation may be at increased risk for certain events known to be associated with each procedure.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:15/4/2016
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