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
- CardioMEMS Patient Electronics System
- 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