Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22390 |
| Brand Name: | Simulator, invasive blood pressure |
| Model: | |
| Affected: | Model EVHRS |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Issue: | The manufacturer have received reports of Out of Range error messages for the Edwards ClearSight Heart Reference Sensor. These complaints have increased in the last six (6) months. An analysis of EVHRS Out of Range complaints led to the determination that the product is not meeting the current labelled shelf life (expiry date) of 730 days (2 years) from the date of manufacture |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/12/2017 |
