ClearSight, Model No. EVHRS Heart Reference Sensor. The… recallZ-1732-2015 · Edwards Lifesciences, LLC · initiated May 18, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
FDA root cause category: Device Design
What the company is doing
Edwards Lifesciences sent an URGENT Product Notification letter dated May 12, 2015, to all affected customers. The letter informed customers that Edwards Lifesciences has received reports that a component of the ClearSight System can be damaged if not handled properly. The letter informs customers of the problems identified and the actions to be taken. Customers with questions are instructed to call Edwards Technical Support. For questions regarding this recall call 949-250-2500.
Recall details
- Recall number
- Z-1732-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 18, 2015
- Posted by the FDA
- Jun 9, 2015
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 1,309 units total (696 units in US)
- Product code
- DXN
- FDA submissions
- K140312
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Estonia, Italy, Romania, Sweden, Austria, Finland, Kuwait, Saudi Arabia, Switzerland, Bahrain, France, Netherlands, Slovenia, Turkey, Belgium, Great Britain, Oman, Slovakia, South Africa, Bulgaria, Greece, Poland, South Africa, United Arab Emirates, Czech Republic, Hungary, Portugal, Spain, Denmark, Ireland, and Qatar.
Product description
ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Code information (models, lots, serial numbers)
All serial numbers. From 600104000221 to 600104005025
Other devices under the same FDA submission
3 devices cleared under K140312 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EV1000 EVPMPEdwards Lifesciences LLC · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE1 report
- CLEARSIGHT CSCSEdwards Lifesciences LLC · PLETHYSMOGRAPH, IMPEDANCE1 report
- CLEARSIGHT CSCMEdwards Lifesciences LLC · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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