FDA Device recall Z-0218-2024
CardioMEMS Patient Electronic System (PES), Model Number CM1100
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of CardioMEMS Patient Electronic System (PES), Model Number CM1100 by St Jude Medical, citing potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0218-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-04 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Reason
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Identifiers
| code_info | Model Number CM1100; UDI/DI: 05414734509800; Serial Numbers: P150800220, P150800222, P150800226, P150800240, P150800242…Model Number CM1100; UDI/DI: 05414734509800; Serial Numbers: P150800220, P150800222, P150800226, P150800240, P150800242, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800273, P150800277, P150900313, P150900315, P150900318, P150900319, P150900322, P150900333, P150900334, P150900335, P150900337, P150900343, P150900344, P150900349, P150900350, P160100406, P160100410, P160100412, P160100414, P160100416, P160100419, P160100422, P160200429, P160200434, P160200435, P160200440, P160200442, P160200451, P160200452, P160200453, P160200456, P160200459, P160200464, P160200466, P160200469, P160200476, P160200479, P160200480, P160200486, P160200487, P160200488, P160200489, P160200490, P160200493, P160200498, P160200505, P160200511, P160200512, P160200515, P160200518, P160200521, P160200524, P160200527, P160200528, P160200529, P160200530, P160200535, P160200538, P160200539, P160200540, P160200545, P160200548, P160200552, P16 |
|---|
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-0218-2024%22
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