Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20042 |
| Brand Name: | Given Bravo® pH Monitoring system |
| Model: | FGS-0312 (5 pack) and FGS-0313 (1 pack) |
| Affected: | |
| 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: | Given Imaging Inc (USA) |
| Issue: | There have been three reports from customers related to patients having allergic reactions to the nickel content in the stainless steel trocar needle that attaches the Bravo® capsule to the esophageal mucosa. Allergic reactions can include hives, itching or oral numbness. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/4/2016 |
