Z-1221-2023Class II
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System...
Abbott Medical / initiated 2023-02-07 / Open, Classified / root cause: design
St. Jude Medical began a recall of CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1221-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Abbott Medical
- Product
- 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.
- Product code
- MOM System, Hemodynamic, Implantable
- 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).
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Abbott notified consignees on about 02/07/2023 via hand-delivery of the letter within the US. The letter instructed consignees to continue to follow CardioMEMS Instructions for Use (IFU). Abbott will notify patients of the emissions issue. If you suspect a CardioMEMS Electronics System has interfered with another medical device during use, report the event to Abbott Remote Care Technical Support at 1-844-MYCMEMS (692-6367) (US). Customers were also instructed to complete and return the acknowledgement and receipt form. Abbott notified patients on about 02/07/2023 via mailed letter. Customers were instructed that they could continue use of their CardioMEMS System and that their doctor has been notified of the issue as well. If there is suspicion that interference may be occurring during a sensor reading or any other quality issues, please report it to: Abbott Technical Support at 1-844-MYCMEMS (692-6367) (US); Monday-Friday: 8am-8pm EST
- Quantity in commerce
- 1,905 units
- 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.
- Product codes and lots
- 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, 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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, 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M180808851, M180808852, M180808853, M180808854, M181008860, M181008861, M181008862, M181008863, M181008865, M181008866, M181008867, M181008868, M181008872, M181008873, M181008874, M181008875, M181008876, M181008877, M181008878, M181008882, M181008883, M181008884, M181008885, M181008887, M181008888, M181008889, M181008890, M181008891, M181008892, M181008893, M181008894, M181008895, M181008896, M181008897, M181008898, M181008899, M181108904, M181108905, M181108907, M181108908, M181108910, M181108912, M181108913, M181208914, M181208916, M181208917, M181208918, M181208919, M181208920, M181208921, M181208922, M181208923, M181208924, M190108925, M190108927, M190108929, M190108930, M190108931, M190108933, M190108934, M190108935, M190108936, M190108956, M190208964, M190208965, M190208966, M190208967, M190208968, M190208969, M190208970, M190208971, M190208972, M190208973, M190208974, M190208975, M190208987, M190208988, M190208989, M190208990, M190208992, M190208993, M190208994, M190208995, M190208996, M190300005, M190300006, M190300007, M190300008, M190300009, M190300010, M190300011, M190300014, M190300015, M190300016, M190300017, M190300018, M190300019, M190400005, M190400006, M190400007, M190400008, M190400010, M190500019, M190500042, M190500043, M190500052, M190600005, M190700001, M190700002, M190700003, M190700004, M190700005, M190800008, M190800009, M190800011, M190800012, M190800013, M190800014, M190800015, M190800016, M190800017, M190800018, M190800027, M190800028, M190800029, M190800030, M190800031, M190900001, M190900002, M190900005, M190900024, M190900025, M190900026, M190900028, M190900032, M190900034, M190900035, M191000001, M191000003, M191000004, M191000005, M191000006, M191000007, M191000008, M191000009, M191000010, M191000011, M191100008, M191100009, M191100010, M191100011, M191200001, M191200002, M191200003, M191200004, M191200005, M200100001, M200100003, M200100004, M200100005, M200100006, M200100007, M200200001, M200200002, M200200003, M200200004, M200200009, M200300001, M200300006, M200300009, M200400001, M200400002, M200400004, M200400005, M200400017, M200400018, M200400019, M200400023, M200400024, M200500002, M200500003, M200500004, M200500005, M200500006, M200500007, M200500008, M200500009, M200500010, M200600001, M200600002, M200600003, M200600004, M200600005, M200600006, M200600007, M200600008, M200600011, M200600012, M200600013, M200600015, M200600017, M200600020, M200600021, M200600022, M200600023, M200700001, M200700007, M200700015, M200700026, M200700027, M200700028, M200700029, M200700030, M200700031, M200700032, M200800001, M200800002, M200800003, M200800004, M200800005, M200800006, M200800007, M200800008, M200800009, M200800010, M200800011, M200800012, M200800013, M200800014, M200800015, M200800016, M200800017, M200900001, M200900002, M200900003, M200900004, M200900005, M200900006, M200900007, M200900008, M200900009, M200900010, M200900011, M200900012, M200900013, M200900014, M200900015, 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1218-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1219-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1220-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1221-2023 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.