CardioMEMS™ CM1010Recalls & reported problems
Cardiomems, Inc. · 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.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734509176), received between Oct 24, 2018 and Oct 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (1 report).
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.
Recalls naming this device
- 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-1219-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Sparking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2018Sparking; Sparking
IT WAS REPORTED THE PATIENT OBSERVED SPARKS COMING OUT AND A BURNING SMELL WHILE ATTEMPTING TO POWER ON THE UNIT. THE UNIT WAS REPLACED WHICH RESOLVED THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8001928 ↗
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
- 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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