—#137006

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.

FDA product code: DXN — System, Measurement, Blood-Pressure, Non-Invasive
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K140312
Affected lot / code info: All serial numbers. From 600104000221 to 600104005025

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

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.

Timeline

Recall initiated: 2015-05-18
Posted by FDA: 2015-06-09
Terminated: 2015-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137006. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.