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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- St. Jude Medical
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1219-2023
Related Recalls
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.