Safety Alert for Trade name: Clearsight. Technical Name: EVHRS Cardiac Reference Sensor. ANVISA registration number: 80219050157. Risk class: III. Model affected: EVHRS. Serial numbers affected: 600104021640; 600104011080; 600104011081; 600104011084; 600104011088; 600104011091; 600104021642; 600104011085; 600104011087; 600104011078

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Actions to be taken by the user: • Please complete the enclosed Knowledge Form. For your convenience, we pre-populate the form with the affected units that you have received. Please follow the instructions on the enclosed Knowledge Form to complete the recall process. This will provide support to determine the product replacement schedule to minimize any potential supply disruption. • Because the inventory of Cardiac Reference Sensors is limited, an Edwards sales representative or local Customer Service will contact you to schedule the replacement. • If you find the message "HRS Out of Range" on the EV1000 NI Clinical Platform (ClearSight Platform), please contact your local Edwards Lifesciences Customer Service representative. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 08/12/2017 - Date of notification notice to Anvisa: 12/21/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "