CardioMEMS Patient and Hospital Electronics System (2018-06-15)

Starting date:

June 15, 2018

Posting date:

June 29, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device, Biologic/vaccine

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67148

• 
  Reason
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  Affected products

Affected products

1. CardioMEMS Patient Electronics System
2. CardioMEMS Hospital Electronics System

Reason

A small number of CardioMEMS hospital electronics systems (model CM3000) and patient electronics system (model CM1100) may deliver a system error, known as error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false error 5 message due to an incorrectly configured component within the device electronics.

Affected products