St. Jude Medical: CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, 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.

Recall number

Z-1219-2023

Recalling firm

St. Jude Medical

Product

CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, 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.

Status

Open, Classified

Initiated

2023-02-07

Posted

2023-03-03

Terminated

not on file

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).

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

200 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.

Lot, serial or model codes

UDI/DI 05414734509176, Serial Numbers: M140300439, M140300440, M140300441, M140300445, M140300446, M140300447, M140300449, M140300450, M140300451, M140300454, M140300458, M140300459, M140300460, M140300463, M140500480, M140500486, M140800987, M140800988, M140800992, M140800995, M140801002, M140801003, M140801004, M140801007, M140801010, M140801011, M141001528, M141001529, M141001530, M141001531, M141001536, M141001539, M141001541, M141001544, M141001545, M141001546, M141101678, M141101681, M141101682, M141101683, M141101684, M141101685, M141101686, M141101693, M141101696, M141101697, M141101700, M141101701, M141101703, M141101705, M141101706, M150102038, M150102039, M150102049, M150102052, M150102054, M150102055, M150102059, M150102061, M150102062, M150102064, M150102066, M150102399, M150102402, M150102404, M150102409, M150102410, M150102414, M150102416, M150202537, M150202538, M150202541, M150202542, M150202544, M150202545, M150302658, M150302660, M150302662, M150302664, M150302666, M150302667, M150302669, M150302673, M150302680, M150302682, M150302683, M150302687, M150302689, M150302690, M150302692, M150302694, M150302695, M150302702, M150302703, M150302707, M150302711, M150302712, M150302713, M150302716, M150302721, M150302723, M150302724, M150302725, M150302729, M150302737, M150302739, M150302742, M150302747, M150302748, M150302751, M150302755, M150302757, M150302758, M150302759, M150302762, M150302769, M150302773, M150302777, M150302778, M150302779, M150302780, M150302782, M150302783, M150302786, M150403048, M150403050, M150403051, M150403057, M150403066, M150805139, M150805143, M150805151, M150805154, M150805155, M150805156, M150805158, M150805160, M150805161, M150805162, M150805166, M150905677, M150905680, M150905682, M150905683, M150905685, M150905688, M150905689, M150905691, M150905692, M150905697, M150905698, M150905699, M150905702, M150905703, M150905704, M150905706, M150905707, M150905708, M150905709, M150905711, M150905714, M151206628, M151206631, M151206633, M151206636, M151206637, M151206641, M151206644, M151206645, M151206647, M151206648, M151206651, M151206655, M151206659, M151206662, M151206665, M160206849, M160206853, M160206854, M160206857, M160206861, M160206867, M160206869, M160206872, M160206876, M160206879, M160206880, M160206882, M160206885, M160206888, M160206896, M160206899, M160206900, M160206902, M160206903, M160206906, M160807699, M160807700, M160807701, M160807772.

510(k) numbers

not on file

PMA numbers

["P100045"]

Product code

MOM

Firm FEI

3004936110

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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