CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary

Summary

The FDA issued a Class II for CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The by St. Jude Medical. Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital E.

Details

Product Description

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.

Lot/Code Info: 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, 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M200900016, M200900017, M200900018, M200900019, M200900020, M200900021, M201000003, M201000004, M201000005, M201000006, M201000007, M201000008, M201000009, M201000010, M201000011, M201000012, M201000013, M201000015, M201000018, M201000019, M201000020, M201000021, M201100001, M201100002, M201100003, M201100004, M201100005, M201100006, M201100007, M201100008, M201100059, M201100060, M201100062, M201100063, M201100064, M201100065, M201100066, M201100067, M201100068, M201200001, M201200002, M201200003, M201200005, M201200006, M210100001, M210100002, M210100003, M210100005, M210100006, M210100007, M210100008, M210100010, M210100011, M210100012, M210100013, M210100014, M210100015, M210100016, M210100017, M210100019, M210100020, M210100021, M210200001, M210200002, M210200003, M210200004, M210200005, M210200006, M210200007, M210200008, M210200009, M210200010, M210200012, M210200013, M210200014, M210200015, M210200016, M210200017, M210200018, M210200019, M210200025, M210200030, M210200031, 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 Affected: 1,905 units

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).

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-07

Company