Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CardioMEMS Heart Failure System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CardioMEMS Heart Failure Systemsee related information
Date Initiated by FirmFebruary 03, 2025
Date PostedMarch 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1427-2025
Recall Event ID 96326
PMA NumberP100045 
Product Classification System, hemodynamic, implantable - Product Code MOM
ProductCardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
Code Information UDI-DI code: 05414734510035 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 Population 1 Serial Numbers: M220300120 M220700122 M221100043 M221100062¿ M230300014 M231100047 M240100001¿ M240100040 In addition, 4 CM3100 have no serial number and are located at Treating Clinic Population 2: Serial Numbers: M220300029 M220300031 M220300041 M220300069 M220300079 M220300113 M220300162 M220700130 M220700131 M220700140 M220900031 M220900038 M220900109 M221000019 M221100013 M230200053 M230500034 M230900025 M231100031 M231100057 M240100066 M240100074 M240500083 In addition, seven device with no serial number - located at Treating or Consulting Clinic Population 3: Serial Numbers: M220200009 M220200013 M220200022 M220200045 M220300001 M220300003 M220300005 M220300007 M220300010 M220300016 M220300019 M220300034 M220300036 M220300045 M220300047 M220300048 M220300061 M220300076 M220300078 M220300081 M220300085 M220300089 M220300090 M220300093 M220300098 M220300110 M220300112 M220300118 M220300128 M220300129 M220300133 M220300152 M220300155 M220300157 M220300160 M220300161 M220300166 M220700030 M220700032 M220700043 M220700044 M220700051 M220700057 M220700062 M220700065 M220700078 M220700084 M220700091 M220700101 M220700106 M220700119 M220700121 M220700134 M220700138 M220700141 M220900021 M220900028 M220900032 M220900040 M220900041 M220900044 M220900074 M220900078 M220900082 M220900087 M220900093 M220900096 M220900103 M220900113 M220900122 M220900123 M221000014 M221000015 M221000022 M221000029 M221000045 M221100010 M221100016 M221100026 M221100045 M221100048 M221100057 M221100066 M230100006 M230100017 M230200020 M230200034 M230200036 M230200041 M230200046 M230200066 M230200072 M230200073 M230300004 M230300010 M230300012 M230300013 M230300025 M230300034 M230300043 M230400005 M230400012 M230400018 M230400019 M230400021 M230400022 M230400023 M230400025 M230400029 M230400031 M230400032 M230400039 M230400041 M230400043 M230400050 M230500007 M230500015 M230500024 M230900011 M230900013 M230900014 M230900015 M230900017 M230900030 M230900034 M231100026 M231100027 M231100030 M231100032 M231100046 M231100051 M231100056 M231100061 M231100071 M231100073 M231200001 M240100004 M240100011 M240100012 M240100015 M240100028 M240100032 M240100035 M240100037 M240100043 M240100063 M240100067 M240100070 M240100073 M240100088 M240500051 M240500056 M240500059 M240500061 M240500073 M240500076 M240500079 M240500086 M240500095 M240500096 M240500098 M240500100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000
FEI Number 3004936110
Recalling Firm/
Manufacturer		 St. Jude Medical
387 Technology Cir Nw Ste 500
Atlanta GA 30313-2424
For Additional Information ContactMr. Cole Heath,
651-421-3655
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionRecall involves 3 populations of users associated with patient profile duplication situations. Customer Notifications were hand-delivered to healthcare providers between 2/3 and 2/14/2025: Population 1 was notified that an issue was identified where Merlin.net creates duplicate patient profiles after a follow-up session with a CM3100. Population 1 instructed to: "Review Appendix A to identify CM3100 Hospital Systems and affected patients (Patient A and Patient B). "Make appointment with Abbott representative for on-site visit. "Pause use of CM3100 or CM3000 Hospital System to perform follow-up sessions for the affected patients(Patient A or B) until site visit that will enable Abbott to correct patient profiles and CM3100 units. "Avoid using CardioMEMS data for patients (Patient A and B) that was sent between the Impacted Date listed in Appendix A and the date the patient profiles are corrected as this data may not be accurate. Populations 2 and 3 were notified that 2 issues were identified: 1) similar issue as population 1, 2) Hospital System follow-up session readings may appear in another patients profile. Population 2 instructed to: "Review Appendix A to identify included CM3100 Hospital Systems and affected patients. "Work with Abbott representative to make an appointment for an on-site visit. "Avoid performing follow-up sessions for any impacted patients (Patients A or B) using any CM3100 orCM3000 Hospital System until the site visit has corrected patient profiles and CM3100 units. "Avoid using CardioMEMS data for patients after the profile duplication date listed in Appendix A until Abbott representative provides support during the on-site visit to restore the patient profile data to accuracy. Population 3 is being notified due to their system may potentially be affect by the 2 issues and instructed to: 1. Power on CM3100 and ensure it has strong, stable network connectivity. 2. Once connectivity is achieved, wait for 10 minutes without navigating away fr
Quantity in Commerce193 devices
DistributionU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA WI, and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MOM
-
-