PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 1, 2018 Initiated: June 14, 2018 #Z-2522-2018

Product Description

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

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.

Details

Recalling Firm
Abbott Laboratories, Inc.
Units Affected
2521 units
Distribution
US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled? ▼
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000. Recalled by Abbott Laboratories, Inc.. Units affected: 2521 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2522-2018.

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