Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27354
Brand Name:MITG - Bravo® pH Monitoring system
Model:
Affected:Multiple 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:Given Imaging Inc (USA)
Issue:The manufacturer has received reports where the Bravo™ reflux capsule failing is to attach to the oesophageal mucosa. In cases where the capsule fails to attach to the oesophageal mucosa, the potential exists for aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:1/3/2021
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