CardioMEMS™ CM1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734509169), received between Jun 20, 2018 and Mar 8, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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 18, 2026.

Recalls naming this device

1. Feb 7, 2023Class IIOpen, Classified

   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).

   Z-1218-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2023Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE POWER SUPPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504232 ↗
• MalfunctionMar 8, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING THERMAL DAMAGE TO THE PRINTED CIRCUIT BOARD OF THE CARDIOMEMS PATIENT ELECTRONIC UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441003 ↗
• MalfunctionApr 17, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD SMOKE LIKE SMELL. THE PATIENT WAS NOT HARMED AND ISSUE WAS RESOLVED BY REPLACING THE UNIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523217 ↗
• MalfunctionDec 10, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. A REPLACEMENT UNIT MAY RESOLVE THE ISSUE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147623 ↗
• MalfunctionJul 12, 2018Smoking; Smoking

  IT WAS REPORTED THAT THE PATIENT'S ELECTRONIC UNIT WOULD NOT TURN ON AFTER THE PATIENT HEARD A POPPING SOUND AND SMELLED SMOKE COMING FROM IT. THE PATIENT WAS NOT INJURED WHEN THE POPPING OCCURRED. A REPLACEMENT UNIT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681934 ↗
• MalfunctionJun 21, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. A REPLACEMENT UNIT MAY RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7627765 ↗
• MalfunctionJun 20, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. A REPLACEMENT UNIT MAY RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7623912 ↗
• MalfunctionJun 20, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. A REPLACEMENT UNIT MAY RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7620350 ↗