CardioMEMS™ CM3000 (UDI 05414734509244)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734509244), received between Jun 21, 2018 and Mar 21, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Failure to Read Input Signal; No Tactile Prompts/Feedback; Failure to Read Input Signal; No Tactile Prompts/Feedback

  IT WAS REPORTED THAT A CARDIOMEMS IMPLANT PROCEDURE WAS ABORTED DUE TO HOSPITAL ELECTRONICS SYSTEM SIGNAL ACQUISITION ISSUES. THE RHC AND LHC PROCEDURES WERE NOT BEING PERFORMED PRIMARILY FOR THE IMPLANT. THE PATIENT WAS IMPLANTED 5 DAYS LATER WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949495 ↗
• InjuryFeb 8, 2024Mechanical Problem; Mechanical Problem

  DURING THE CARDIOMEMS IMPLANT PROCEDURE THE HOSPITAL ELECTRONICS UNIT DISPLAYED AN ERROR 5 MESSAGE INDICATING THE TIME OF DAY CLOCK FOR THE SYSTEM WAS OFF. THE USER WAS UNABLE TO LOG IN TO THE UNIT DUE TO THE ERROR AND COULD NOT PROCEED WITH THE CASE SO THE PROCEDURE WAS ABANDONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE IS NO INFORMATION TO INDICATE THAT THIS ERROR 5 WAS RELATED TO THE INCORRECT SPEED SETTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666877 ↗
• MalfunctionNov 3, 2023Material Frayed; Material Frayed

  EXPOSED AND FRAYED WIRES OF THE PRINTER CORD WERE DISCOVERED DURING EVALUATION OF THE DEVICE. THE HOSPITAL ELECTRONIC SYSTEM WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT/HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065492 ↗
• MalfunctionMar 6, 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 8397319 ↗
• MalfunctionJun 21, 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 Known Impact Or Consequence To Patient

  MAUDE report 7627880 ↗