# FDA recall Z-2522-2018

> **Abbott Laboratories, Inc.** · Class II · device recall initiated 2018-06-14.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** Z-2522-2018
- **Recalling firm:** Abbott Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-14
- **Report date:** 2018-08-01
- **Termination date:** 2021-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2018

## Citation

> AI Analytics. FDA recall Z-2522-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2522-2018. Source: US FDA. Licensed CC0.

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