| 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 |
|
| 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 |