CardioMEMS™ CM1100Recalls & reported problems
Cardiomems, Inc. · Patient Electronics System · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This CardioMEMS CM1100 is the patient electronics unit for a pulmonary artery sensor. Its 4,380 adverse event reports mostly describe frayed material, incorrect messages on the display and failure to power up. The reports include no deaths and 59 injuries. Three recalls name this device: the open ones cover a power plug that can fray and radio emissions that may interfere with other medical devices, and the closed one covers a system error message.
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
- 4,257
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 4,257 adverse event reports that list this exact device (DI 05414734509800), received between Jun 15, 2018 and Sep 30, 2026 — classified as 57 injuries, 4,200 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (2,523 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. 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
- Oct 4, 2023Class IIOpen, Classified
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Z-0218-2024 · Root cause: Device Design · Recall details · FDA record ↗
- 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-1220-2023 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 14, 2018Class IITerminated
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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Frayed2,523
- Device Displays Incorrect Message1,143
- Sparking453
- Failure to Power Up377
- Intermittent Loss of Power117
- Mechanical Problem111
- Application Program Freezes or Fails to Launch61
- Loose or Intermittent Connection53
Patient problems
- No Clinical Signs, Symptoms or Conditions3,044
- No Consequences Or Impact To Patient781
- No Known Impact Or Consequence To Patient449
- Electric Shock14
- Dyspnea7
- Hypervolemia5
- Heart Failure/Congestive Heart Failure3
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 4,257 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952187 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950651 ↗MalfunctionSep 30, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946723 ↗MalfunctionSep 29, 2026Material Frayed
During device analysis, it was found that the Patient Electronics System handheld cable had frayed and exposed wires.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932030 ↗MalfunctionSep 29, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931508 ↗MalfunctionSep 29, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931398 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902293 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900544 ↗MalfunctionSep 25, 2026Break
Exposed and frayed wires of the power extension cable were discovered during evaluation of the device. The Patient Electronic Unit was replaced and there were no adverse consequences reported by the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899921 ↗MalfunctionSep 25, 2026Material Frayed
The patient reported exposed and frayed wires of the power connector plug. The Patient Electronic Unit was replaced and there were no adverse consequences reported by the patient
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896504 ↗MalfunctionSep 24, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888508 ↗MalfunctionSep 24, 2026Material Frayed
The patient reported exposed and frayed wires of the Power Connector Plug. The Patient Electronic Unit was replaced and there were no adverse consequences reported by the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886441 ↗MalfunctionSep 23, 2026Material Frayed; Sparking
The patient reported exposed wires and sparking of the Power Extension Cable. The Patient Electronics Device was replaced and there were no adverse consequences reported by the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871452 ↗MalfunctionSep 18, 2026Electrical /Electronic Property Problem
Thermal damage of the PCB board was discovered during evaluation of the device. The Patient Electronic Unit was replaced and there were no adverse consequences reported by the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817034 ↗MalfunctionSep 18, 2026Material Frayed
The patient reported exposed and frayed wires of the power extension cable. The Patient Electronic Unit was replaced and there were no adverse consequences reported by the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816932 ↗MalfunctionSep 17, 2026Intermittent Loss of Power
The investigation of the device revealed a finding of frayed and exposed wires on the power extension cable of the device. The Patient Electronic Unit was replaced and there were no adverse consequences reported by the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801505 ↗MalfunctionSep 16, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793337 ↗MalfunctionSep 16, 2026Material Frayed; Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793225 ↗MalfunctionSep 16, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792738 ↗MalfunctionSep 16, 2026Material Frayed
The patient reported exposed wires on Handheld Cable. The Patient Electronic Unit was replaced and there were no adverse consequences reported by the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790669 ↗MalfunctionSep 2, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50562558 ↗MalfunctionAug 27, 2026Break
This report is to advise of an incidental finding during product analysis confirming physical damage to the CardioMEMS I3 printed circuit board. Damaged area with a hole was discovered on a conductor on the I3 printed circuit board. Damage resulted in potential for exposed low voltage components.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478828 ↗MalfunctionAug 26, 2026Material Frayed; Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458503 ↗MalfunctionAug 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433749 ↗MalfunctionAug 24, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410207 ↗
Other System, hemodynamic, implantable devices
- CardioMEMS™ CM2000Cardiomems, Inc. · System, hemodynamic, implantable1 recall170 deaths4,294 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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