FDA Device recall Z-1224-2023
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami… by St Jude Medical, citing select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1224-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-07 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, 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
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
Identifiers
| code_info | UDI/DI 05415067029331: M140100179, M140100180, M140100181, M140100182, M140100183, M140100184, M140100185, M140100186,…UDI/DI 05415067029331: M140100179, M140100180, M140100181, M140100182, M140100183, M140100184, M140100185, M140100186, M140200187, M140200188, M140200190, M140200191, M140200193, M140200196, M140200204, M140200205, M140200213, M140200215, M140200216, M140200218, M140200220, M140200221, M140200223, M140200224, M140200226, M140200228, M140200230, M140200233, M140200234, M140200235, M140200237, M140200238, M140200240, M140200243, M140200245, M140400469, M140400470, M140400471, M140400472, M140400474, M140600522, M140600530, M140600532, M140600536, M140600537, M140600538, M140600541, M140600542, M140600543, M140600545, M140600546, M140700687, M140700688, M140700689, M140700690, M140700691, M140700692, M140700693, M140700694, M140700698, M140700699, M140700700, M140700701, M140700703, M140700705, M140700710, M140700712, M140700713, M140700714, M140700715, M140700717, M140700718, M140700721, M140700722, M140700725, M140700726, M140700799, M140700800, M140700801, M140700804, M140700806, M1407 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1224-2023%22
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