ForeSight IQ FSESLIQRecalls & reported problems
Edwards Lifesciences LLC · ForeSight Sensor Large IQ · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103219616), received between Apr 3, 2026 and Apr 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF THE FORESIGHT SENSOR THE TOTAL HEMOGLOBIN WAS OFF BY MORE THAN 1 G. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782754 ↗MalfunctionApr 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF THE FORESIGHT SENSOR THE TOTAL HEMOGLOBIN WAS OFF BY MORE THAN 1 G. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780658 ↗
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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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