Z-1219-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units
Product 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.
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).
Distribution Pattern
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.
Code Information
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.