| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00503-1 |
| Product Name/Description |
Edwards Lifesciences Heart Reference Sensor
Model Number - EVHRS
ARTG Number - 219809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
A component of the ClearSight System can be damaged if not handled properly. The Heart Reference Sensor (Model Number EVHRS) compensates for pressure differences between the finger cuff and the heart. The finger component of the EVHRS may be damaged if subjected to moderate to significant surface impact. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Edwards Lifesciences is providing work around instructions to assist end users in determining whether the Heart Reference Sensor has been damaged. An insert, included with the recall letter, will be provided with all new EVHRS devices and the Operating Manual of the EV1000NI will be updated on its next release.
Edwards Lifesciences is currently working on design changes to avoid the potential for damage to the device and to detect whether damage has been sustained during use. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 222 601 Edwards Customer Service |