CardioMEMS™ CM1110Recalls & reported problems
St. Jude Medical, Inc. · Power Supply · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734509916), received between Apr 26, 2019 and Apr 26, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Material Frayed1
- Sparking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2019Material Frayed; Sparking; Material Frayed; Sparking
IT WAS REPORTED ALLEGED SPARKS CAME FROM THE POWER CORD OF THE PATIENT'S EXTERNAL DEVICE UNIT WHILE DISCONNECTED FROM THE PATIENT'S DEVICE. FURTHER EXAMINATION OF THE POWER CORD REVEALED THE CAUSE WAS BELIEVED TO BE CHEWING FOR A PET. A REPLACEMENT DEVICE WAS SENT TO THE PATIENT AND ADDRESSED THE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8555878 ↗
Other System, hemodynamic, implantable devices
- CardioMEMS™ CM1100Cardiomems, Inc. · System, hemodynamic, implantable3 recalls4,257 reports
- 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
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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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