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Terminated

CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000

FDA Recall Z-2522-2018 · Posted None

Recalling FirmAbbott Laboratories, Inc.
Recall StatusTerminated
Product CodeMOM
Date Initiated2018-06-14
Date Terminated2021-09-08
Product Quantity2521 units

Reason for Recall

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.

Firm Action

The firm notified the hospital and clinics of the recall on 06/14/2018 and the patients on 06/15/2018 by letter. The letter explained that the units 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. The firm is requesting return of the units. Patients may contact Abbott Remote Care Technical Support at 1-844-692-6367 for assistance and further information.

Root Cause

Process control

Distribution Pattern

US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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