Edwards Lifesciences, LLC: Medical Device Recall in 2015 - (Recall #: Z-1732-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 18, 2015

Date Posted: June 17, 2015

Recall Number: Z-1732-2015

Event ID: 71246

Reason for Recall:

Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

Status: Terminated

Product Quantity: 1,309 units total (696 units in US)

Code Information:

All serial numbers. From 600104000221 to 600104005025

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated