Edwards Lifesciences, LLC: ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodyna

Is my product affected?

ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

• UPC 600104000221
• UPC 600104005025

Check against the official notice below — it lists the full affected range.

What happened

Edwards Lifesciences is recalling 1,309 units of the ClearSight System, a noninvasive blood pressure measurement device, due to potential damage to the finger component of the Heart Reference Sensor. The affected units were distributed worldwide, including 696 units in the United States and units to 30 other countries including Australia, Canada, and various European and Middle Eastern nations. All serial numbers from 600104000221 to 600104005025 are included in the recall.

The recall notice does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged. 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. Quantity: 1,309 units total (696 units in US) Lot/code info: All serial numbers. From 600104000221 to 600104005025

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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