Class II Recall

CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary

Summary

The FDA issued a Class II for CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, 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

Source

Device Recall

External ID

Z-1219-2023

Action Date

2023-03-15

Status

Ongoing

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.

Lot/Code Info: 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.

Quantity Affected: 200 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).

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-07

Company

St. Jude Medical

Atlanta, GA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.

St. Jude Medical has 13 FDA actions in our database, including 13 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (St. Jude Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does St. Jude Medical have FDA actions?

St. Jude Medical has 13 FDA actions in our database, including 13 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1219-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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