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RecallWatchMedical Device Safety
Class IIOngoingZ-1427-2025

St. Jude Medical recalls CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Mode…

St. Jude MedicalAtlanta, GA, United StatesReported Apr 2, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • CardioMEMS 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 treatmentUDI
    UDI-DI codeModel CM3100
    194 affected lots
    M220300120M220700122M221100043M230300014M231100047M240100040CM3100M220300029
    +186 moreM220300031M220300041M220300069M220300079M220300113M220300162M220700130M220700131M220700140M220900031M220900038M220900109M221000019M221100013M230200053M230500034M230900025M231100031M231100057M240100066M240100074M240500083M220200009M220200013M220200022M220200045M220300001M220300003M220300005M220300007M220300010M220300016M220300019M220300034M220300036M220300045M220300047M220300048M220300061M220300076M220300078M220300081M220300085M220300089M220300090M220300093M220300098M220300110M220300112M220300118M220300128M220300129M220300133M220300152M220300155M220300157M220300160M220300161M220300166M220700030M220700032M220700043M220700044M220700051M220700057M220700062M220700065M220700078M220700084M220700091M220700101M220700106M220700119M220700121M220700134M220700138M220700141M220900021M220900028M220900032M220900040M220900041M220900044M220900074M220900078M220900082M220900087M220900093M220900096M220900103M220900113M220900122M220900123M221000014M221000015M221000022M221000029M221000045M221100010M221100016M221100026M221100045M221100048M221100057M221100066M230100006M230100017M230200020M230200034M230200036M230200041M230200046M230200066M230200072M230200073M230300004M230300010M230300012M230300013M230300025M230300034M230300043M230400005M230400012M230400018M230400019M230400021M230400022M230400023M230400025M230400029M230400031M230400032M230400039M230400041M230400043M230400050M230500007M230500015M230500024M230900011M230900013M230900014M230900015M230900017M230900030M230900034M231100026M231100027M231100030M231100032M231100046M231100051M231100056M231100061M231100071M231100073M231200001M240100004M240100011M240100012M240100015M240100028M240100032M240100035M240100037M240100043M240100063M240100067M240100070M240100073M240100088M240500051M240500056M240500059M240500061M240500073M240500076M240500079M240500086M240500095M240500096M240500098M240500100CM4000MN6000

What the firm is doing

Recall 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

DistributionShow details

U.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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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