FDAJune 14, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

UPCs

0541473450980005415067029331

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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