ClearSight Heart Reference Sensor (2017-12-11)

Starting date:

December 11, 2017

Posting date:

January 8, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65542

• 
  Reason
• 
  Affected products

Affected Products

CLEARSIGHT HEART REFERENCE SENSOR

Reason

The current product as well as the affiliated labeling contains an expiration date of two years. Through investigation and analysis of complaint data, Edwards Lifesciences discovered that hrs units are susceptible to experiencing an "hrs out of range" error message in the EV1000 platform that are beyond six months from the date of manufacture.

Affected products