CardioMEMS™ CM3100Recalls & reported problems

Summary

The FDA's MAUDE database contains 419 adverse event reports that list this exact device (DI 05415067034724), received between Mar 8, 2023 and Mar 25, 2026 — classified as 2 injuries, 417 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (370 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 7, 2023Open, Classified

   Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.

   Z-1225-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 419 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Break; Loose or Intermittent Connection; Noise, Audible

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES ON THE INTERNAL CABLE CONNECTING THE WAND PORT TO THE TELEMETRY PRINTED CIRCUIT BOARD (PCB). THE HOSPITAL ELECTRONIC UNIT WAS REPLACED AND THERE WERE NO PATIENTS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687416 ↗
• MalfunctionMar 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-(B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643072 ↗
• MalfunctionMar 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643057 ↗
• MalfunctionMar 12, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581432 ↗
• MalfunctionMar 9, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-2026-08395 WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546491 ↗
• MalfunctionMar 9, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544178 ↗
• MalfunctionMar 9, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544164 ↗
• MalfunctionMar 9, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544114 ↗
• MalfunctionMar 9, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543953 ↗
• MalfunctionMar 5, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT (B)(6) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT (B)(6). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR: (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518648 ↗
• MalfunctionMar 5, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-2026-08379 WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518632 ↗
• MalfunctionFeb 24, 2026Application Program Problem

  THE DEVICE IS INCLUDED IN THE FA-Q125-HF-1 CM3100 DUPLICATED PATIENT PROFILE IN HF CLOUD INITIATED ON (B)(6) 2025. ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (B)(6) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435663 ↗
• MalfunctionFeb 24, 2026Application Program Problem

  THE DEVICE IS INCLUDED IN THE FA-Q125-HF-1 CM3100 DUPLICATED PATIENT PROFILE IN HF CLOUD INITIATED ON 30JAN2025. ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-(B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT [X]).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435589 ↗
• MalfunctionFeb 23, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421970 ↗
• MalfunctionFeb 23, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421943 ↗
• MalfunctionFeb 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-2026-05546 WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387807 ↗
• MalfunctionFeb 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT: (B)(6) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT: (B)(6)). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR: (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387790 ↗
• MalfunctionFeb 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-(B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387785 ↗
• MalfunctionFeb 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-2026-06016 WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387761 ↗
• MalfunctionFeb 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-(B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387744 ↗
• MalfunctionFeb 19, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-2026-06019 WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387734 ↗
• MalfunctionFeb 13, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337262 ↗
• MalfunctionFeb 13, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337230 ↗
• MalfunctionFeb 13, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. (B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT B).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337203 ↗
• MalfunctionFeb 13, 2026Application Program Problem

  ABBOTT R&D INTERNAL TESTING AND CODE REVIEW IDENTIFIED AN ISSUE WHERE THE READINGS FROM ONE CM3100 SYSTEM SESSION FOR ONE PATIENT (PATIENT A) WERE INCORRECTLY REPORTED UNDER A DIFFERENT PATIENT (PATIENT B). NO PATIENT INJURY WAS REPORTED. THE ISSUE IS CURRENTLY UNDER INVESTIGATION. MDR-(B)(4) WAS CREATED FOR THE SECOND PATIENT (PATIENT A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337195 ↗