Health product recall

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

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

A. CardioMEMS Patient Electronics System

Lot or serial number

SN: P180107823

Model or catalog number

CM1100

Companies
Manufacturer

St. Jude Medical

387 Technology Cirle NW

Atlanta

30313

Georgia

UNITED STATES


B. CardioMEMS Hospital Electronics System

Lot or serial number

SN: M171108427

Model or catalog number

CM3000

Companies
Manufacturer

St. Jude Medical

387 Technology Cirle NW

Atlanta

30313

Georgia

UNITED STATES