Abbott Laboratories, Inc. recalls CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital…

Recall date

June 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2522-2018

FDA classification

Class II

Brand / firm

Abbott Laboratories, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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