CLASS II ONGOING Device recall · Reported 15 Mar 2023 · FDA Enforcement Report

CardioMEMS HF System Hospital Electronics System (HES) recalled

St. Jude Medical is recalling CardioMEMS HF System Hospital Electronics System (HES), distributed nationwide in the US. The recall was initiated on 7 Feb 2023 and the FDA has classified it as Class II.

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Lot, batch or date codesUDI/DI 05415067029331, Serial Numbers: 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, 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M210200032, M210200033, M210200034, M210200035, M210300003, M210300004, M210300005, M210300006, M210300007, M210300009, M210300010, M210300011, M210300012, M210300013, M210300015, M210300016, M210300018, M210300019, M210300020, M210300022, M210300023, M210300024, M210300025, M210400007, M210400008, M210400009, M210400010, M210400011, M210400012, M210400013, M210400014, M210400015, M210400027, M210400028, M210400029, M210400030, M210400031, M210400032, M210400033, M210400034, M210400035, M210400036, M210400037, M210400038, M210400039, M210400040, M210400041, M210400042, M210400043, M210400044, M210400045, M210400046, M210400047, M210400048, M210400049, M210400050, M210500001, M210500003, M210500004, M210500005, M210500006, M210500007, M210500008, M210500009, M210500010, M210500011, M210500012, M210500013, M210500014, M210500015, M210500016, M210500017, M210500018, M210500019, M210500020, M210500021, M210500022, M210500023, M210500024, M210500025, M210500026, M210500027, M210500028, M210500029, M210500030, M210500031, M210500032, M210500033, M210500034, M210500036, M210500037, M210500039, M210500040, M210500041, M210800002, M210800003, M210800005, M210800006, M210800007, M210800008, M210800009, M210800010, M210800011, M210800012, M210800013, M210800014, M210800015, M210800016, M210800017, M210800019, M210800020, M210800021, M210800022, M210800023, M210800024, M210800025, M210800026, M210800027, M210800028, M210800029, M210800030, M210800031, M210800032, M210800033, M210900001, M210900003, M210900004, M210900005, M210900006, M210900007, M210900008, M210900010, M210900011, M210900012, M210900013, M210900014, M210900015, M210900016, M210900017, M210900018, M210900019, M210900020, M210900021, M210900022, M210900023, M210900024, M210900025, M211000001, M211000003, M211000004, M211000005, M211000007, M211000008, M211000009, M211000010, M211000011, M211000012, M211000013, M211000014, M211200001, M211200002, M211200003, M211200004, M211200005, M140600524, M140700798, M140700803, M140800826, M140800866, M140901181, M140901183, M141201855, M141201864, M150202510, M150202513, M150402908, M150402910, M150402933, M150503406, M150503408, M150503425, M150905423, M151005977, M151005980, M151005981, M151005982, M151005984, M151005985, M151005986, M151005987, M151005991, M151005992, M151005993, M151206552, M151206557, M160307208, M160307222, M160307225, M160307231, M160307235, M160707618, M160707619, M160707621, M160707622, M160707631, M160707632, M160707633, M160707636, M161208051, M170108105, M170608276, M170608278, M170608279, M170608280, M170608281, M170608283, M170608284, M170608288, M170608291, M170608292, M170608299, M170608300, M170608304, M170608306, M170608307, M170708322, M170808330, M170808331, M170808332, M170808333, M170808334, M170808335, M170808348, M170808349, M170808350, M170808351, M171108405, M171108435, M180208513, M180308522, M180308524, M180308528, M180308530, M180308531, M180308532, M180308533, M180308534, M180408558, M180408559, M180408560, M180408561, M180408592, M180508594, M180508595, M180508613, M180508614, M180508615, M180508622, M180508623, M180508624, M180608640, M180608664, M180608665, M180608666, M180608675, M180608676, M180608685, M180608686, M180608704, M180608705, M180608706, M180608715, M180608716, M180708824, M180708825, M180708826, M180808828, M180808829, M180808838, M180808839, M180808842, M180808844, M180808846, M180808847, M180808848, M180808849, M180808850, M180908856, M180908858, M180908859, M181008869, M181008879, M181008880, M181008901, M181008902, M181008903, M190108937, M190108938, M190108939, M190108940, M190108941, M190108942, M190108943, M190108945, M190108947, M190108948, M190108949, M190108950, M190108951, M190108952, M190108953, M190108954, M190300001, M190300003, M190300004, M190400001, M190400003, M190400004, M190500001, M190500002, M190500003, M190500004, M190500005, M190500006, M190500007, M190500008, M190500009, M190500016, M190500017, M190500018, M190500021, M190500022, M190500044, M190500045, M190500046, M190500047, M190500048, M190500049, M190500050, M190500051, M190600001, M190600002, M190600006, M190600007, M190600008, M190600009, M190600010, M190600011, M190600012, M190600013, M190600014, M190600015, M190600017, M190600018, M190600019, M190600020, M190600021, M190600023, M190600026, M190600027, M190600028, M190600029, M190700006, M190700007, M190700008, M190700009, M190700010, M190700011, M190700012, M190700013, M190700014, M190700015, M190700016, M190700017, M190700018, M190700019, M190700020, M190700021, M190700022, M190700023, M190700024, M190700025, M190700026, M190700027, M190700029, M190700030, M190700031, M190700032, M190700033, M190700034, M190700035, M190700036, M190800002, M190800003, M190800004, M190800005, M190800006, M190800007, M190800019, M190800020, M190800021, M190800022, M190800023, M190800024, M190800025, M190800026, M190900039, M190900041, M200700002, M200700003, M200700004, M200700005, M200700006, M200700008, M200700009, M200700010, M200700011, M200700012, M200700013, M200700014, M200700016, M200700017, M200700018, M200700019, M200700020, M200700021, M200700022, M200700024, M200700025, M210200020, M210200021, M210200022, M210200023, M210200024, M210200026, M210200027, M210200028, M210200029, M210200038, M210200039, M210300001, M210300002, M210300014, M210300017, M210400001, M210400002, M210400003, M210400004, M210400006, M210400018, M210400019, M210400020, M210400021, M210400022, M210400023, M210400025, M210400026, M210500042, M210500043, M210600001, M210600002, M210600003, M210600004, M210600005, M210600006, M210600007, M210800035, M210800036, M210800037, M210800038, M210800039, M210800040, M210800041, M210800042, M210800043, M210800044, M210800045, M210800046, M211000023, M211000024, M211000025, M220600002, M220600003, M220600004, M220600005, M220600006, M220600008, M220600011, M220600034, M220600036, M220600037, M220600038, M220600039, M220600040, M220600041, M220600042, M220700189, M220700192, M161208048

Quantity recalled1,905 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1221-2023
FDA event ID: 91610
Recalling firm: St. Jude Medical, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Feb 2023
FDA classified: 3 Mar 2023
Reported: 15 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

7 Feb 2023	Recall initiated by company
3 Mar 2023	Classified by FDA	+24 days
15 Mar 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CardioMEMS HF System Hospital Electronics System (HES), 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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 05415067029331, Serial Numbers: 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, M140700817, M140700818, M140800820, M140800821, M140800822, M140800825, M140800827, M140800828, M140800829, M140800833, M140800835, M140800837, M140800838, M140800839, M140800841, M140800842, M140800846, M140800848, M140800849, M140800850, M140800853, M140800855, M140800856, M140800859, M140800861, M140800862, M140800864, M140800867, M140800868, M140800869, M140800872, M140800874, M140800876, M140800877, M140800879, M140800880, M140800881, M140800883, M140800886, M140800887, M140800890, M140800891, M140800895, M140800896, M140800918, M140800919, M140800922, M140800925, M140800926, M140901157, M140901158, M140901159, M140901160, M140901161, M140901162, M140901163, M140901164, M140901166, M140901169, M140901172, M140901174, M140901175, M140901177, M140901184, M140901185, M140901186, M141001337, M141001339, M141001341, M141001344, M141001345, M141001353, M141001354, M141001355, M141001356, M141001358, M141001359, M141001360, M141001361, M141001362, M141001363, M141001366, M141201849, M141201857, M141201859, M141201861, M141201862, M141201863, M141201865, M141201866, M141201867, M141201869, M141201870, M141201871, M141201873, M141201874, M141201876, M141201879, M141201880, M141201882, M141201883, M141201885, M141201886, M141201887, M141201889, M141201890, M141201891, M141201893, M141201894, M141201895, M141201897, M141201898, M141201899, M141201900, M141201901, M141201902, M141201903, M141201904, M141201906, M150102237, M150102238, M150102239, M150102241, M150102243, M150102245, M150102246, M150102248, M150102253, M150102254, M150102255, M150102257, M150102259, M150102260, M150102261, M150102263, M150102265, M150102266, M150202497, M150202498, M150202499, M150202502, M150202503, M150202504, M150202505, M150202507, M150202509, M150202512, M150202514, M150202516, M150202526, M150302647, M150302649, M150302650, M150302652, M150302655, M150402907, M150402911, M150402912, M150402914, M150402916, M150402918, M150402919, M150402920, M150402921, M150402922, M150402924, M150402925, M150402926, M150402927, M150402929, M150402931, M150402932, M150402934, M150402935, M150402937, M150402938, M150402941, M150402942, M150402943, M150402944, M150402945, M150402946, M150403187, M150403188, M150403189, M150403190, M150403191, M150403192, M150403193, M150403194, M150503377, M150503378, M150503379, M150503380, M150503381, M150503384, M150503385, M150503390, M150503391, M150503393, M150503397, M150503398, M150503400, M150503401, M150503404, M150503407, M150503409, M150503410, M150503411, M150503413, M150503414, M150503415, M150503416, M150503419, M150503420, M150503423, M150503424, M150704378, M150704379, M150704380, M150704381, M150704383, M150704384, M150704385, M150704386, M150704387, M150704389, M150704391, M150704393, M150704397, M150704398, M150704399, M150704401, M150704403, M150704405, M150704407, M150704412, M150704413, M150704414, M150704416, M150704417, M150704418, M150704419, M150704420, M150704421, M150704422, M150704423, M150704424, M150704426, M150804897, M150804899, M150804901, M150804903, M150804904, M150804906, M150804907, M150804908, M150804909, M150804910, M150804911, M150804912, M150804914, M150804915, M150804916, M150804917, M150804918, M150804919, M150804920, M150804921, M150804922, M150804923, M150804924, M150804926, M150804927, M150804929, M150804932, M150804933, M150804934, M150804935, M150804936, M150804937, M150804938, M150804939, M150804943, M150804944, M150804945, M150804947, M150804948, M150804949, M150804950, M150804951, M150804952, M150804953, M150804954, M150804955, M150905408, M150905410, M150905411, M150905412, M150905413, M150905414, M150905415, M150905416, M150905417, M150905418, M150905419, M150905420, M150905424, M150905426, M150905427, M150905428, M150905429, M150905430, M150905431, M150905432, M150905433, M150905435, M150905717, M150905718, M150905719, M150905721, M150905722, M150905724, M150905728, M150905729, M150905730, M150905731, M150905732, M150905734, M150905739, M150905740, M150905741, M150905742, M150905745, M151005983, M151005988, M151005989, M151005994, M151005995, M151106357, M151106359, M151106362, M151106363, M151106364, M151106366, M151106367, M151106368, M151106369, M151106371, M151106372, M151106375, M151106376, M151106381, M151106382, M151106385, M151106387, M151106389, M151106390, M151106391, M151106392, M151106393, M151106394, M151106396, M151106397, M151106398, M151106399, M151106400, M151106401, M151106403, M151106404, M151106405, M151206527, M151206528, M151206530, M151206531, M151206533, M151206537, M151206539, M151206540, M151206541, M151206542, M151206544, M151206545, M151206546, M151206548, M151206549, M151206550, M151206551, M151206554, M151206556, M151206558, M151206559, M151206560, M151206561, M151206563, M151206566, M160307210, M160307211, M160307214, M160307219, M160307221, M160307223, M160307224, M160307226, M160307227, M160307234, M160707625, M160807677, M160807678, M160807679, M160807680, M160807682, M160807683, M160807684, M160807685, M160807687, M160807690, M160807692, M161107927, M161107928, M161107929, M161107930, M161107931, M161107932, M161107933, M161107934, M161107935, M161107936, M161107937, M161107938, M161107939, M161107940, M161107941, M161107942, M161107943, M161107944, M161107945, M161207947, M161207948, M161207953, M161207955, M161207956, M161207957, M161207958, M161207959, M161207960, M161207961, M161207962, M161207963, M161207964, M161207965, M161207968, M161207969, M161207970, M161207972, M161207973, M161207974, M161207975, M161207976, M161207978, M161207980, M161207981, M161207983, M161207984, M161207985, M161208049, M161208065, M161208066, M161208067, M161208068, M161208069, M161208070, M161208071, M161208072, M161208073, M161208074, M161208075, M161208076, M161208077, M161208078, M161208079, M161208080, M161208081, M161208082, M161208084, M170108086, M170108087, M170108088, M170108089, M170108090, M170108091, M170108092, M170108093, M170108095, M170108096, M170108097, M170108098, M170108100, M170108101, M170108102, M170108103, M170108104, M170108106, M170108107, M170108108, M170108109, M170108110, M170108111, M170108112, M170108113, M170108114, M170108115, M170108119, M170108120, M170108122, M170108123, M170108124, M170108125, M170108126, M170108127, M170108130, M170108131, M170108132, M170108133, M170108134, M170108135, M170108136, M170108137, M170108138, M170108140, M170108141, M170108142, M170108144, M170108145, M170108146, M170108147, M170108148, M170108149, M170108150, M170108153, M170108154, M170108155, M170108156, M170108157, M170208158, M170208159, M170208160, M170208161, M170208162, M170208163, M170208164, M170208165, M170208166, M170208167, M170208168, M170208169, M170208170, M170208171, M170208172, M170208173, M170208174, M170208175, M170208176, M170208177, M170208178, M170208179, M170208181, M170208182, M170208183, M170208184, M170208185, M170208187, M170308188, M170308190, M170308191, M170308192, M170308193, M170308194, M170308195, M170308196, 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M200700012, M200700013, M200700014, M200700016, M200700017, M200700018, M200700019, M200700020, M200700021, M200700022, M200700024, M200700025, M210200020, M210200021, M210200022, M210200023, M210200024, M210200026, M210200027, M210200028, M210200029, M210200038, M210200039, M210300001, M210300002, M210300014, M210300017, M210400001, M210400002, M210400003, M210400004, M210400006, M210400018, M210400019, M210400020, M210400021, M210400022, M210400023, M210400025, M210400026, M210500042, M210500043, M210600001, M210600002, M210600003, M210600004, M210600005, M210600006, M210600007, M210800035, M210800036, M210800037, M210800038, M210800039, M210800040, M210800041, M210800042, M210800043, M210800044, M210800045, M210800046, M211000023, M211000024, M211000025, M220600002, M220600003, M220600004, M220600005, M220600006, M220600008, M220600011, M220600034, M220600036, M220600037, M220600038, M220600039, M220600040, M220600041, M220600042, M220700189, M220700192, M161208048

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 91610

Reported	Class	Recall	Company	Reason	Where
15 Mar 2023	CLASS II	CardioMEMS HF System Patient Electronics System (PES) recalled	St. Jude Medical	Device Malfunction	Nationwide
15 Mar 2023	CLASS II	CardioMEMS HF System Patient Electronics System (PES) recalled	St. Jude Medical	Device Malfunction	Nationwide

More recalls from St. Jude Medical

All 47

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025Device	CLASS II	CardioMEMS Heart Failure (HF) System that consist recalled	St. Jude Medical	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Merlin.net Patient Care Network recalled by St. Jude Medical	St. Jude Medical	Device Malfunction	13 states
24 Jul 2024Device	CLASS II	Agilis NxT Steerable Introducer recalled by St. Jude Medical	St. Jude Medical	Other	MN

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide