FDA Device recall Z-1219-2023
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn… by St Jude Medical, citing radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1219-2023 |
| 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 Patient Electronics System (PES), Model number CM1010, 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
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).
Identifiers
| code_info | UDI/DI 05414734509176, Serial Numbers: M140300439, M140300440, M140300441, M140300445, M140300446, M140300447, M1403004…UDI/DI 05414734509176, Serial Numbers: M140300439, M140300440, M140300441, M140300445, M140300446, M140300447, M140300449, M140300450, M140300451, M140300454, M140300458, M140300459, M140300460, M140300463, M140500480, M140500486, M140800987, M140800988, M140800992, M140800995, M140801002, M140801003, M140801004, M140801007, M140801010, M140801011, M141001528, M141001529, M141001530, M141001531, M141001536, M141001539, M141001541, M141001544, M141001545, M141001546, M141101678, M141101681, M141101682, M141101683, M141101684, M141101685, M141101686, M141101693, M141101696, M141101697, M141101700, M141101701, M141101703, M141101705, M141101706, M150102038, M150102039, M150102049, M150102052, M150102054, M150102055, M150102059, M150102061, M150102062, M150102064, M150102066, M150102399, M150102402, M150102404, M150102409, M150102410, M150102414, M150102416, M150202537, M150202538, M150202541, M150202542, M150202544, M150202545, M150302658, M150302660, M150302662, M150302664, M150302666, M |
|---|
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-1219-2023%22
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