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Recall Observatory FDA recall evidence

Device 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.

Z-1732-2015

May 18, 2015

Class II

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 71246
Status
Terminated
Classification
Class II
Quantity
1,309 units total (696 units in US)
Official record key
device-enforcement:Z-1732-2015

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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