Z-1732-2015Class II

ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger...

Name: Z-1732-2015 ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger...
Creator: Edwards Lifesciences, LLC
Published: 2015-05-18
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2015-05-18 / Terminated / root cause: design

FDA source

Edwards Lifesciences, LLC began a recall of ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and... on 2015-05-18. FDA classified it as Class II and gives the reason as "Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1732-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Posted: 2015-06-09
Terminated: 2015-11-06
Recalling firm: Edwards Lifesciences LLC
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.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1,309 units total (696 units in US)
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 codes and lots: All serial numbers. From 600104000221 to 600104005025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1732-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1732-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09

Product code DXN

K140312Class IIEv1000 Clinical Platform with Clearsight Tm Finger Cuff or Clearsight Tm SystemEdwards Lifesciences, LLC / cleared 2014-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)