Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24329 |
| Brand Name: | Patient monitor, multiparameter |
| Model: | Model Numbers: EV1000A, EV1000NI, EV1000CS |
| Affected: | Lot Numbers: All lots for models listed |
| 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 |
| Brand Name: | EV1000 Clinical Platform NI |
| Model: | Model Numbers: EV1000A, EV1000NI, EV1000CS |
| Affected: | Lot Numbers: All lots for models listed |
| 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 has identified a potential risk, which may occur during the use of the EV1000 clinical platform with minimally invasive and non-invasive technologies. Edwards Lifesciences has received a limited number of reports regarding fluid ingress into the AC power outlet on both the EV1000A power adaptor and the EV1000NI pump unit. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/3/2019 |
