CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web A

FDA device recall Z-1427-2025 · posted 2025-03-21 · Open, Classified

Recall details

Recalling firm

St. Jude Medical

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.

Action taken

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

Root cause

Software design

Status

Open, Classified

Product code

MOM

Quantity affected

193 devices

Distribution

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,

Date initiated

2025-02-03

Date posted

2025-03-21

Location

Atlanta, GA