--- title: "CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, T... — FDA record Z-1220-2023 | Is It on Recall" description: "Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics" url: https://isitonrecall.com/recall/fda-device-z-1220-2023-cardiomems-hf-system-patient-electronics-system-pes-model-number-cm1100-the-cardiomems-hf-system-pro/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmona... — FDA record Z-1220-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Feb 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, 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). - **Classification**: Class II - **Recalling firm**: St. Jude Medical - **Quantity**: 34,905 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1220-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1220-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI/DI 05414734509800, Serial Numbers: P150800220, P150800221, P150800222, P150800224, P150800226, P150800227, P150800228, P150800240, P150800241, P150800242, P150800243, P150800244, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800272, P150800273, P150800274, P150800276, P150800277, P150800278, P150900312, P150900313, P150900318, P150900319, P150900321, P150900322, P150900324, P150900325, P150900326, P150900327, P150900328, P150900329, P150900331, P150900332, P150900334, P150900335, P150900336, P150900337, P150900338, P150900339, P150900341, P150900342, P150900343, P150900344, P150900346, P150900349, P150900350, P160100404, P160100405, P160100406, P160100407, P160100408, P160100410, P160100411, P160100412, P160100413, P160100414, P160100415, P160100416, P160100418, P160100419, P160100420, P160100421, P160200423, P160200425, P160200428, P160200429, P160200430, P160200431, P160200432, P160200434, P160200435, P160200436, P160200437, P160200438, P160200439, P160200440, P160200441, P160200442, P160200445, P160200448, P160200449, P160200450, P160200451, P160200452, P160200453, P160200456, P160200457, P160200458, P160200459, P160200460, P160200464, P160200465, P160200466, P160200469, P160200470, P160200473, P160200475, P160200476, P160200479, P160200481, P160200483, P160200484, P160200485, P160200486, P160200487, P160200488, P160200489, P160200490, P160200493, P160200494, P160200495, P160200496, P160200497, P160200498, P160200499, P160200500, P160200502, P160200503, P160200504, P160200505, P160200507, P160200508, P160200509, P160200510, P160200511, P160200512, P160200513, P160200514, P160200515, P160200516, P160200517, P160200518, P160200519, P160200520, P160200521, P160200522, P160200523, P160200524, P160200525, P160200526, P160200527, P160200528, P160200529, P160200530, P160200531, P160200532, P160200533, P160200534, P160200535, P160200536, P160200537, P160200538, P160200539, P160200540, P160200541, P160200543, P160200544, P160200545, P160200546, P160200547, P160200548, P160200549, P160200551, P160200552, P160200553, P160200554, P160200555, P160200557, P160200558, P160200559, P160200560, P160200563, P160200564, P160200565, P160200566, P160200567, P160200568, P160200569, P160200571, P160200572, P160200573, P160200574, P160200575, P160200576, P160200577, P160200580, P160200581, P160200582, P160500583, P160500584, P160500585, P160500587, P160500588, P160500590, P160500591, P160500592, P160500593, P160500595, P160500597, P160500598, P160500599, P160500602, P160600603, P160600606, P160600607, P160600608, P160600609, P160600610, P160600611, P160600615, P160600616, P160600617, P160600618, P160600619, P160600621, P160600623, P160600624, P160600625, P160600627, P160600628, P160600629, P160600630, P160600631, P160600632, P160600633, P160600634, P160600635, P160600636, P160600637, P160600638, P160600639, P160600640, P160600642, P160600644, P160600645, P160600646, P160600647, P160600649, P160600650, P160600651, P160600652, P160600654, P160600656, P160600657, P160600658, P160600659, P160600661, P160600662, P160600663, P160600664, P160600666, P160600668, P160600669, P160600671, P160600672, P160600673, P160600674, P160600675, P160600676, P160600677, P160600678, P160600680, P160600681, P160600682, P160600683, P160600684, P160600685, P160600686, P160600687, P160600688, P160600691, P160600692, P160600693, P160600694, P160600695, P160600697, P160600699, P160600700, P160600703, P160600712, P160600714, P160600715, P160600717, P160600719, P160600720, P160600723, P160600724, P160600727, P160600730, P160600731, P160600732, P160900733, P160900735, P160900736, P160900737, P160900738, P160900739, P160900740, P160900741, P160900742, P160900744, P160900745, P160900746, P160900747, P160900748, P160900749, P160900750, P160900751, P160900753, P160900754, P160900756, P160900758, P160900759, P160900760, P160900761, P160900762, P160900763, P160900764, P160900765, P160900766, P160900767, P160900768, P160900769, P160900771, P160900773, P160900774, P160900775, P160900776, P160900777, P160900778, P160900779, P160900780, P160900781, P160900782, P160900783, P160900784, P160900785, P160900786, P160900787, P160900788, P160900789, P160900790, P160900791, P160900792, P161000793, P161000794, P161000796, P161000797, P161000798, P161000799, P161000800, P161000801, P161000803, P161000804, P161000805, P161000806, P161000807, P161000810, P161000811, P161000812, P161000813, P161000814, P161000815, P161000816, P161000818, P161000819, P161000820, P161000821, P161000822, P161000823, P161000824, P161000825, P161000826, P161000827, P161000828, P161000829, P161000830, P161000831, P161000832, P161000843, P161000844, P161000845, P161000846, P161000847, P161000848, P161000849, P161000850, P161000851, P161000852, P161000853, P161000854, P161000855, P161000857, P161000858, P161000859, P161000860, P161000862, P161000863, P161000864, P161000865, P161000866, P161000867, P161000868, P161000869, P161000870, P161000871, P161000872, P161000883, P161000884, P161000885, P161000886, P161000887, P161000888, P161000889, P161000890, P161000891, P161000892, P161000893, P161000894, P161000895, P161000897, P161000898, P161000899, P161000900, P161000901, P161000902, P161000903, P161000904, P161000905, P161000907, P161000908, P161000909, P161000910, P161000911, P161000912, P161000914, P161000915, P161000916, P161000917, P161000918, P161000919, P161000920, P161000922, P161000923, P161000924, P161000925, P161000926, P161000927, P161000930, P161000931, P161000932, P161000933, P161000934, P161000935, P161000936, P161000937, P161000938, P161000939, P161000941, P161000942, P161000943, P161000944, P161000945, P161000946, P161000947, P161000949, P161000950, P161000951, P161000952, P161000953, P161000954, P161000955, P161000956, P161000957, P161000958, P161000959, P161000960, P161000962, P161000963, P161000964, P161000965, P161000966, P161000967, P161000968, P161000971, P161000972, P161000973, P161000974, P161000975, P161000976, P161000977, P161000978, P161000979, P161000980, P161000981, P161000984, P161000985, P161000986, P161000987, P161000989, P161000991, P161000992, P161000994, P161000995, P161000996, P161000997, P161000998, P161000999, P161001000, P161001001, P161001002, P161001003, P161001004, P161001005, P161001006, P161001007, P161001008, P161001009, P161001010, P161001011, P161001012, P161001013, P161001014, P161001015, P161001016, P161001018, P161001020, P161001021, P161001022, P161001023, P161001024, P161001025, P161001026, P161001027, P161001028, P161001029, P161001030, P161001031, P161001032, P161001036, P161001037, P161001039, P161001040, P161001041, P161001042, P161001043, P161001044, P161001045, P161001046, P161001047, P161001048, P161001049, P161001051, P161001052, P161001053, P161001054, P161001055, P161001057, P161001059, P161001060, P161001061, P161001062, P161001064, P161001065, P161001066, P161001067, P161001068, P161001069, P161001070, P161001071, P161001074, P161001075, P161001076, P161001077, P161001078, P161001079, P161001080, P161001082, P161001083, P161001084, P161001085, P161001086, P161001088, P161001089, P161001090, P161001091, P161001092, P161001094, P161001095, P161001096, P161001097, P161001098, P161001100, P161001101, P161001102, P161001103, P161001104, P161001105, P161001107, P161001108, P161001109, P161001112, P161001113, P161001114, P161001115, P161001116, P161001117, P161001118, P161001119, P161001120, P161001121, P161001122, P161001123, P161001124, P161001125, P161001126, P161001127, P161001128, P161001129, P161001130, P161001131, P161001132, P161001133, P161001134, P161001135, P161001136, P161001137, P161001138, P161001140, P161001141, P161001143, P161001144, P161001145, P161001147, P161001148, P161001149, P161001150, P161001151, P161001152, P161001153, P161001154, P161001155, P161001156, P161001157, P161001158, P161001159, P161001160, P161001161, P161001162, P161001163, P161001165, P161001166, P161001167, P161001168, P161001170, P161001171, P161001172, P161001173, P161001174, P161001175, P161001176, P161001177, P161001178, P161001179, P161001180, P161001181, P161001182, P161001183, P161001184, P161001186, P161001187, P161001188, P161001190, P161001191, P161001192, P161001194, P161001195, P161001197, P161001198, P161001199, P161001200, P161001201, P161001202, P161001203, P161001206, P161001207, P161001208, P161001209, P161001210, P161001211, P161001212, P161101213, P161101214, P161101215, P161101216, P161101217, P161101218, P161101219, P161101220, P161101221, P161101222, P161101223, P161101224, P161101225, P161101226, P161101227, P161101228, P161101229, P161101230, P161101231, P161101232, P161101234, P161101235, P161101236, P161101239, P161101240, P161101241, P161101243, P161101244, P161101245, P161101246, P161101248, P161101249, P161101250, P161101251, P161101273, P161101276, P161101277, P161101278, P161101279, P161101280, P161101282, P161101283, P161101284, P161101285, P161101286, P161101287, P161101288, P161101289, P161101290, P161101291, P161101292, P161101293, P161101294, P161101295, P161101296, P161101297, P161101298, P161101299, P161101300, P161101301, P161101302, P161101303, P161101304, P161101305, P161101306, P161101307, P161101308, P161101309, P161101310, P161101311, P161101312, P161101313, P161101314, P161101315, P161101316, P161101317, P161101318, P161101320, P161101321, P161101323, P161101324, P161101326, P161101328, P161101329, P161101330, P161101331, P161101332, P161101333, P161101334, P161101336, P161101337, P161101338, P161101339, P161101340, P161101341, P161101342, P161101343, P161101344, P161101346, P161101348, P161101349, P161101351, P161101352, P161101353, P161101354, P161101355, P161101356, P161101358, P161101359, P161101362, P161101363, P161101364, P161101366, P161101368, P161101369, P161101370, P161101372, P161101373, P161101374, P161101377, P161101380, P161101381, P161101383, P161101384, P161101385, P161101387, P161101388, P161101389, P161101390, P161101391, P161101393, P161101394, P161101395, P161101396, P161101397, P161101398, P161101399, P161101400, P161101401, P161101403, P161101404, P161101405, P161101406, P161101407, P161101408, P161101409, P161101410, P161101412, P161101423, P161101424, P161101425, P161101426, P161101428, P161101429, P161101431, P161101432, P161101433, P161101434, P161101435, P161101437, P161101438, P161101439, P161101440, P161101441, P161101442, P161101443, P161101444, P161101445, P161101446, P161101447, P161101448, P161101450, P161101451, P161101455, P161101456, P161101457, P161101459, P161101460, P161101461, P161101464, P161101465, P161101466, P161101467, P161101468, P161101469, P161101470, P161101471, P161101472, P161101473, P161101474, P161101475, P161101476, P161101477, P161101479, P161101481, P161101482, P161101483, P161101484, P161101486, P161101487, P161101488, P161101489, P161101491, P161101492, P161101493, P161101494, P161101495, P161101496, P161101498, P161101499, P161101500, P161101502, P161101503, P161101504, P161101505, P161101506, P161101508, P161101509, P161101510, P161101511, P161101512, P161101513, P161101514, P161101515, P161101516, P161101517, P161101519, P161101520, P161101521, P161101522, P161101523, P161101524, P161101525, P161101526, P161101527, P161101528, P161101529, P161101530, P161101531, P161101532, P161101533, P161101534, P161101535, P161101536, P161101537, P161101538, P161101539, P161101540, P161101541, P161101542, P161101543, P161101544, P161101545, P161101546, P161101547, P161101548, P161101551, P161101552, P161101553, P161101554, P161101555, P161101556, P161101557, P161101558, P161101559, P161101560, P161101561, P161101562, P161101563, P161101564, P161101567, P161101568, P161101569, P161101570, P161101571, P161101572, P161201573, P161201574, P161201575, P161201576, P161201577, P161201578, P161201581, P161201583, P161201584, P161201585, P161201586, P161201589, P161201593, P161201594, P161201595, P161201597, P161201598, P161201599, P161201600, P161201601, P16120... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1220-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## 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. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Mar 15, 2023 - **Recall initiation date**: Feb 7, 2023 - **Center classification date**: Mar 3, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1220-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [St. Jude Medical records](https://isitonrecall.com/brand/st-jude-medical/)