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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00477-1
Product Name/Description Given Imaging Bravo pH monitoring systems

Bravo pH capsule delivery device, 5-pack
Item Code: FGS-0312

Bravo pH capsule delivery device, 1-pack
Item Code: FGS-0313

ARTG Number: 205795
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/04/2016
Responsible Entity Covidien Pty Ltd
Reason/Issue Medtronic has received three customer complaints related to patients having allergic reactions to the nickel content in the stainless steel trocar needle that attaches the Bravo capsule to the oesophageal mucosa. Allergic reactions can include hives, itching or oral numbness.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic is providing customers with updated user manuals and product package inserts which include information in relation to the metal content of the device and precautions regarding metal allergies. This action has been closed-out on 27/01/2017.
Contact Information 02 9429 3179 - Covidien