HEMOSPHERE HEMDPT1000Recalls & reported problems
Edwards Lifesciences LLC · DPT OUT CABLE · Class 2
Data updated Oct 13, 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 00690103199338), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED, THAT THE HEMDPT1000 HAD A DISCREPANCY TO THE BEDSIDE MONITOR DURING USE. THE SYSTOLIC DIASTOLIC AND MEAN ARTERIAL PRESSURE WERE 20 POINTS DIFFERENT FROM THE PHILLIPS MONITOR. THE HEMOSPHERE WAS READING LOWER CONSISTENTLY, FOR 30 OR MORE MINUTES. NO ERROR MESSAGES WERE PRESENT. THEY EXCHANGED CUFFS CORDS AND DOUBLE CHECKED CONNECTIONS. THERE WAS NO PATIENT HARM. PATIENT DEMOGRAPHICS WERE UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17393713 ↗
Other Adjunctive Predictive Cardiovascular Indicator devices
- HEMOSPHERE HEMPSC100Edwards Lifesciences LLC · Adjunctive Predictive Cardiovascular Indicator4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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