# FDA recall Z-1218-2023

> **St. Jude Medical** · Class II · device recall initiated 2023-02-07.

## Product

CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients.  The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

## Reason for recall

Radiated Radiofrequency (RF) emissions of the  CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.

## Key facts

- **Recall number:** Z-1218-2023
- **Recalling firm:** St. Jude Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-07
- **Report date:** 2023-03-15

- **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-1218-2023

## Citation

> AI Analytics. FDA recall Z-1218-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1218-2023. Source: US FDA. Licensed CC0.

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