CardioMEMS™ CM2000Recalls & reported problems
Cardiomems, Inc. · PA Sensor and Delivery System · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This CardioMEMS CM2000 is an implanted pressure sensor for the pulmonary artery. Its 4,382 adverse event reports mostly describe incorrect pressure readings, and some describe coughing up blood. The reports include 170 deaths and 3,289 injuries. 1 recall names this device: started in February 2023 and still open, it covers sensors that can give inaccurate readings above 2,000 ft.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 4,294
- Deaths reported
- 170
- Injuries reported
- 3,226
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,294 adverse event reports that list this exact device (DI 05414734509237), received between Jun 11, 2018 and Sep 30, 2026 — classified as 170 deaths, 3,226 injuries, 898 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (2,495 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.
Reports received per month
Recalls naming this device
- Feb 7, 2023Class IIOpen, 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-1223-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect Measurement2,495
- Device Sensing Problem712
- Inappropriate Waveform481
- Adverse Event Without Identified Device or Use Problem459
- Insufficient Device Problem Information107
- Migration64
- Difficult to Advance50
- Unable to Obtain Readings38
Patient problems
- No Clinical Signs, Symptoms or Conditions2,968
- No Consequences Or Impact To Patient777
- Hemoptysis139
- Death135
- Dyspnea43
- Hypervolemia41
- No Known Impact Or Consequence To Patient39
- Heart Failure/Congestive Heart Failure34
Recent adverse event reports
The 25 most recent of 4,294 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Incorrect Measurement
Information was received from the healthcare provider on 15SEP2026 that a Right Heart Catheterization was performed on (b)(6) 2026 to confirm the validity of the pressure sensor readings. The sensor was recalibrated, and the mean was decreased by 9.2 mmHg. Readings were observed under the manufacturer's patient care network database.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944882 ↗InjurySep 29, 2026Incorrect Measurement
It was reported that an echocardiogram was performed to assess the accuracy of the CardioMEMS sensor pressures. The sensor was recalibrated and the baseline was decreased by 10.9mmHg.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931476 ↗InjurySep 28, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923715 ↗MalfunctionSep 28, 2026Inappropriate Waveform
The sensor transmitted a dampened waveform reading. The physician is currently monitoring the patient and the sensor readings. There were no adverse consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923498 ↗InjurySep 28, 2026Incorrect Measurement
A right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was recalibrated and the mean was increased by 7.9 mmHg. Readings were observed under the manufacturer's patient care network database.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923409 ↗InjurySep 25, 2026Incorrect Measurement
A right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was not recalibrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901286 ↗InjurySep 25, 2026Incorrect Measurement
A right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was not recalibrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899852 ↗InjurySep 25, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899300 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cough; Hemoptysis
MAUDE report 50896761 ↗MalfunctionSep 25, 2026Inappropriate Waveform
It was reported the sensor transmitted a dampened waveform reading. The provider reported the patient will discontinue readings for this time. There were no adverse consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896687 ↗InjurySep 25, 2026Incorrect Measurement
A right heart catheterization was performed to assess the accuracy of the CardioMEMS sensor pressures. The sensor was recalibrated and the baseline was increased by 13.3 mmHg.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896632 ↗InjurySep 25, 2026Incorrect Measurement
It was reported that a right heart catheterization was performed to assess the accuracy of the CardioMEMS sensor pressures. The sensor was recalibrated and the baseline was increased by 18.5mmHg.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896595 ↗InjurySep 25, 2026Incorrect Measurement
A right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was recalibrated and the mean was increased by 6.7 mmHg. Readings were observed under the manufacturer's patient care network database.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896475 ↗InjurySep 23, 2026Separation Failure
It was reported that during CardioMEMS implant while attempting to deploy the sensor, the proximal loop of the sensor stayed attached to the device sheath. After unsuccessful troubleshooting, which included multiple breath holds and inserting a swan catheter next to the delivery catheter to try to ¿bump¿ the device off, the sensor needed to be snared in order to extract from the patient, and the implant procedure was aborted. An additional access site was used to remove the device. The physician confirmed that this issue caused a clinically significant delay as the procedure took longer than planned due to length of troubleshooting and the intervention needed to remove the device. A second attempt at implant is not scheduled at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869096 ↗InjurySep 18, 2026Incorrect Measurement
A right heart catheterization was performed for unknown reasons and no recalibration was performed. Additional information was requested but has not been provided by the healthcare provider.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816897 ↗InjurySep 17, 2026Difficult or Delayed Separation
During the implant of the sensor, the sensor did not release from the distal end of the delivery catheter. The physician could not remove the sensor from the delivery catheter. The physician had to perform a second access site through the femoral vein to put the swan up. The balloon catheter was able to knock the sensor off of the catheter. The sensor was successfully implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801392 ↗InjurySep 16, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793388 ↗InjurySep 16, 2026Incorrect Measurement
It was reported that the patient's clinical symptoms were not matching the sensor data and a right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was recalibrated and the mean was increased by 12 mmHg. Readings were observed under the manufacturer's patient care network database. Additional information was requested but has not been provided by the healthcare provider.
Patient problems: Insufficient Information
MAUDE report 50787868 ↗InjurySep 16, 2026Incorrect Measurement
A Right Heart Catheterization was performed for unknown reasons. The sensor was not recalibrated. Additional information was requested but has not been provided by the healthcare provider.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787455 ↗MalfunctionSep 16, 2026Inappropriate Waveform
It was confirmed by the Technical Heart Failure Specialist Team that the patient's CardioMEMS waveforms were dampened. The physician is currently monitoring the patient and the sensor readings. There were no adverse consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786939 ↗InjurySep 2, 2026Incorrect Measurement
A right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was not recalibrated. Readings were observed under the manufacturer's patient care network database.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570780 ↗MalfunctionAug 31, 2026Inappropriate Waveform
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519314 ↗InjuryAug 26, 2026Incorrect Measurement
A Right Heart Catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was recalibrated, and the mean was increased by 4.8 mmHg. Readings were observed under the manufacturer's patient care network database.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457083 ↗InjuryAug 10, 2026Incorrect Measurement
A Right Heart Catheterization was performed to confirm the validity of the pressure sensor readings. The CardioMEMS pulmonary artery mean matched the Right Heart Catheterization pulmonary artery mean and no recalibration was needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193375 ↗MalfunctionAug 7, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177332 ↗
Other System, hemodynamic, implantable devices
- CardioMEMS™ CM1100Cardiomems, Inc. · System, hemodynamic, implantable3 recalls4,257 reports
- CardioMEMS™ CM3100Cardiomems, Inc. · System, hemodynamic, implantable1 recall419 reports
- CardioMEMS™ CM3000Cardiomems, Inc. · System, hemodynamic, implantable3 recalls65 reports
- CardioMEMS™ CM1000Cardiomems, Inc. · System, hemodynamic, implantable1 recall8 reports
- CardioMEMS™ CM1010Cardiomems, Inc. · System, hemodynamic, implantable1 recall1 report
- Cordella Sensor Delivery Kit 100303-05Endotronix, Inc. · System, Hemodynamic, Implantable1 death47 reports
- CardioMEMS™ CM3000Cardiomems, Inc. · System, hemodynamic, implantable5 reports
- CardioMEMS™ CM1110St. Jude Medical, Inc. · System, hemodynamic, implantable1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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