CardioMEMS™ CM3000 (UDI 05415067029331)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 05415067029331), received between Jun 15, 2018 and Jan 20, 2026 — classified as 1 injury, 64 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (47 reports).

3 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 7, 2023Open, 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-1221-2023 · Root cause: Device Design · FDA record ↗

2. 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-1224-2023 · Root cause: Device Design · FDA record ↗

3. Jun 14, 2018Terminated

   Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.

   Z-2522-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Break

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES ON THE I2 PRINTER SERIAL CABLE ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118368 ↗
• MalfunctionDec 29, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT THE HOSPITAL ELECTRONICS SYSTEM WAND BROKE OFF CORD RESULTING IN EXPOSED WIRES. THE HOSPITAL ELECTRONICS SYSTEM WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917044 ↗
• MalfunctionDec 16, 2025Break; Material Frayed; Break; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS, IN WHICH THE GLOBAL SYSTEM FOR MOBILE COMMUNICATIONS (GSM) ANTENNA AND PRINTER SERIAL CABLE ASSEMBLY WERE FOUND TO BE BROKEN WITH EXPOSED CIRCUITRY/WIRES. THE HOSPITAL SYSTEM WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED, AND NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817692 ↗
• MalfunctionApr 4, 2025Material Frayed; Noise, Audible; Material Frayed; Noise, Audible

  USER AT THE CLINIC NOTICED THE HOSPITAL ELECTONICS SYSTEM HAS SLIGHTLY FRAYED WIRES ON THE BACK OF THE UNIT. THE HOSPITAL ELECTRONICS SYSTEM WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE USER AT THE CLINIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772217 ↗
• MalfunctionMar 18, 2025Break; Material Frayed; Break; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE HOSPITAL ELECTRONIC SYSTEM HAVING A FUNCTIONALLY DAMAGED GSM ANTENNA. ALSO, THE UNIT¿S PRINTER TEST STEP FAILURE IN INITIAL DIAGNOSTIC TEST CONCLUDED TO BE A DAMAGED I2 EXTERNAL PRINTER SERIAL CABLE ASSEMBLY WITH EXPOSED WIRES. THE HOSPITAL ELECTRONIC SYSTEM WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633266 ↗
• MalfunctionOct 21, 2024Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE PRINTER SERIAL CABLE. THERE WERE NO ADVERSE CONSEQUENCES. THE HOSPITAL ELECTRONIC SYSTEM WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498284 ↗
• MalfunctionApr 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A CAPACITOR APPEARED TO HAVE BEEN BURNT. ALTHOUGH THERE WERE NO REPORTED VISIBLE SMOKE OR FIRE, BURNT COMPONENTS COULD POTENTIALLY INDICATE EVIDENCE OF FIRE OR OTHER ELEMENTS OF EXCESS HEAT. THERE WERE NO ADVERSE CONSEQUENCES FROM THIS EVENT AND THE HOSPITAL ELECTRONIC SYSTEM WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165644 ↗
• MalfunctionApr 8, 2024Electromagnetic Interference; Failure to Read Input Signal; Electromagnetic Interference; Failure to Read Input Signal

  A CARDIOMEMS IMPLANT PROCEDURE WAS COMPLETED. THE IMPLANT PROCEDURE WAS REPORTED TO HAVE BEEN PROLONGED DUE TO DIFFICULTIES CALIBRATING THE SENSOR. NO ADVERSE CONSEQUENCES WERE NOTED, AND THE SENSOR WAS CALIBRATED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19062888 ↗
• MalfunctionAug 27, 2023Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE PRINTER SERIAL CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628971 ↗
• MalfunctionMar 30, 2023Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  IT WAS REPORTED THAT THE HOSPITAL ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. TROUBLESHOOTING RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16652955 ↗
• MalfunctionFeb 10, 2023Failure to Read Input Signal; Failure to Read Input Signal

  PRIOR TO THE IMPLANT PROCEDURE WITH THE PATIENT ALREADY ON THE TABLE WITH VENIPUNCTURE, THE HOSPITAL ELECTRONICS SYSTEM WAS NOT ABLE TO PASS THE DYNAMIC SIGNAL CHECK AND THE PROCEDURE HAD TO BE CANCELLED. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, HOWEVER, ULTIMATELY THE ISSUE COULD NOT BE RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLED PROCEDURE AND THE PROCEDURE WAS RESCHEDULED FOR (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350291 ↗
• MalfunctionDec 14, 2022Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE PRINTER SERIAL CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15975932 ↗
• MalfunctionDec 13, 2022Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE RIGID ANTENNA ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968764 ↗
• MalfunctionNov 30, 2022Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE PRINTER SERIAL CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885365 ↗
• MalfunctionOct 5, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HOSPITAL ELECTRONICS UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. TROUBLESHOOTING THE UNIT WAS ABLE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15542569 ↗
• MalfunctionMay 18, 2022Break; Sparking; Break; Sparking

  THE POWER CORD OF THE PES WAS FRAYED. THE CORD SPARKED AT THE AREA WHERE IT PLUGGED INTO THE POWER SUPPLY. THE POWER CORD AND POWER SUPPLY WERE REPLACED. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THE ISSUE. NO PATIENT WAS INVOLVED. ON (B)(6) 2022, THE HES STILL SPARKED FROM THE ACCESS PLATE AT THE POWER PORT FOLLOWING REPLACEMENT OF THE POWER SUPPLY AND POWER CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431323 ↗
• MalfunctionJul 15, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING DEVICE ANALYSIS, EVIDENCE OF ELECTRICAL OVERSTRESS WAS FOUND ON THE HOSPITAL UNIT CIRCUIT BOARD. THE HOSPITAL UNIT WAS RETURNED FOR AN ERROR 00.

  Patient problems: No Patient Involvement

  MAUDE report 10280105 ↗
• MalfunctionNov 19, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  RELATED MFR NUMBER: 3004936110-2018-00224. 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 9345201 ↗
• MalfunctionNov 6, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  RELATED MFR NUMBER: 3004936110-2018-00260. IT WAS REPORTED THAT THE HOSPITAL 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 9287533 ↗
• MalfunctionSep 13, 2019Device Displays Incorrect Message

  IT WAS REPORTED THAT THE HOSPITAL 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 9027017 ↗
• MalfunctionMay 3, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE HOSPITAL 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 8578354 ↗
• InjuryApr 18, 2019Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED THAT THE HOSPITAL ELECTRONICS SYSTEM BEGAN TO SPARK WHEN BEING PLUGGING IN AND BLACK SMOKE STARTED COMING OUT. CUSTOMER WAS NOT HARMED. ISSUE WAS RESOLVED BY REPLACING THE UNIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529454 ↗
• MalfunctionDec 7, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED (B)(6) THAT THE HOSPITAL 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 8143968 ↗
• MalfunctionAug 14, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE HOSPITAL 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 7782764 ↗
• MalfunctionJul 27, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE HOSPITAL 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 7726288 ↗