Company: Abbott Laboratories, Inc.
Date of Enforcement Report: 8/1/2018
Class II:
PRODUCT
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Recall Number: Z-2522-2018
REASON
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (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.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc, Atlanta, GA on 6/14/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2521 units
DISTRIBUTION
Nationwide and Internationally