FDA Device recall Z-1732-2015
ClearSight, Model No. EVHRS Heart Reference Sensor
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of ClearSight, Model No. EVHRS Heart Reference Sensor by Edwards Lifesciences, citing edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1732-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-18 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Reason
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
Identifiers
| code_info | All serial numbers. From 600104000221 to 600104005025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1732-2015%22
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