HEMOSPHERE HEMPSC100Recalls & reported problems
Edwards Lifesciences LLC · Pressure Cable · Class 2
All models of HemoSphere (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103199321), received between Feb 9, 2024 and Apr 3, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement2
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE THE HEMOSPHERE CABLE PROVIDED INACCURATE VALUES. THE SYSTOLIC BLOOD PRESSURE WAS READING 15 TO 20 POINTS DIFFERENCE FROM THE HEMOSPHERE TO THE ANESTHESIA MONITOR. ONCE THE SUSPECT CABLE WAS EXCHANGED FOR A NEW ONE THE READINGS DISPLAYED AS EXPECTED. THERE WAS NO TREATMENT ADMINISTERED FOR THE INACCURATE VALUES AND NO ALLEGATION OF IS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21764522 ↗MalfunctionJul 25, 2024Incorrect Measurement; Incorrect Measurement
AS REPORTED, WITH THIS HEMOSPHERE PRESSURE CABLE, RANDOM AND UNSTABLE VALUES WERE PROVIDED (MEDWATCH # (B)(4) ). THE SAME CABLE HAD PRESENTED THE SAME ISSUE WITH ANOTHER PATIENT AND DIFFERENT NURSE (MEDWATCH # (B)(4) ). NO FURTHER INFORMATION COULD BE OBTAINED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826310 ↗MalfunctionJul 25, 2024Incorrect Measurement; Incorrect Measurement
AS REPORTED, WITH THIS HEMOSPHERE PRESSURE CABLE, RANDOM AND UNSTABLE VALUES WERE PROVIDED (MEDWATCH #50624). THE SAME CABLE HAD PRESENTED THE SAME ISSUE WITH ANOTHER PATIENT AND DIFFERENT NURSE (MEDWATCH #50621). NO FURTHER INFORMATION COULD BE OBTAINED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826240 ↗MalfunctionFeb 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THERE WERE INACCURATE BLOOD PRESSURE READINGS DURING PATIENT USE. THE PSC100 PRESSURE CABLE WAS CONNECTED TO THE HEMOSPHERE MONITOR. THE READING ON THE HEMOSPHERE MONITOR THAT WAS SENT TO THE PHILLIPS MONITOR DID NOT MATCH. THE NURSE NOTICED THE DIFFERENCE IMMEDIATELY. THERE WERE NO ERROR MESSAGES DISPLAYED. THE DISPLAYED NUMBERS AND WHAT THEY WERE EXPECTED TO BE ARE UNKNOWN. A NEW CABLE WAS EXCHANGED FOR THE SUSPECT CABLE AND IT WAS CONNECTED AND IT RESOLVED THE ISSUE. THERE IS NO PATIENT INJURY. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18673892 ↗
Other Adjunctive Predictive Cardiovascular Indicator devices
- HEMOSPHERE HEMDPT1000Edwards Lifesciences LLC · Adjunctive Predictive Cardiovascular Indicator1 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
- 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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