Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27623 |
| Brand Name: | Cardiac Mapping and Workstation System with Accessories |
| Model: | Model: ENSITE-AMP-02, ENSITE-R-AMP-02 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | St Jude Medical (USA) |
| Issue: | The manufacturer has identified that when using the EnSiteTM X EP System Amplifier (models ENSITE-AMP-02 and ENSITE-R-AMP-02) that there is the potential for depressed pins in the HD port used to connect the 80-pin Catheter Input Module (CIM) to the amplifier (used for connecting non-Abbott catheters). |
| Recall action type: | Recall |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/4/2021 |
