ForeSight FSESLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690103208146), received between Jan 16, 2024 and Aug 11, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K143675); they may or may not involve this specific model.

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF FORESIGHT SENSOR, IN AN OPEN HEART SURGERY, THE NUMBER WAS GREATER THAN 90 HOWEVER WHEN CHANGED OUT THE NEW SENSOR MONITORED THE PATIENT IN THE 70S. A NEW SENSOR WAS APPLIED BY THE PHYSICIAN WHICH WORKED AS EXPECTED. THERE WAS NO PATIENT INJURY NOR WAS ANY TREATMENT ADMINISTERED BASED ON INACCURATE VALUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771689 ↗
• MalfunctionDec 1, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE OBVIOUSLY HIGH READING OF ABOVE 90 WAS DISPLAYED SOON AFTER APPLYING A SET OF FORESIGHT SENSORS ON THE PATIENT'S HEAD. THE SENSORS WERE REPLACED, AND THE MEASUREMENT WAS STABLE AT AROUND 65. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815822 ↗
• MalfunctionNov 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THE FSESL FORESIGHT SENSORS READINGS WERE WITHIN NORMAL RANGE FOR 3 HOURS BUT THEN SLOWLY DRIFTED TO 55 AND 59 WHILE ASSESSING CEREBRAL OXIMETRY. INTERVENTION INCLUDED THE DOCTOR TRYING TO IMPROVE THE OXIMETRY READING BY ADJUSTING ETCO2 BLOOD PRESSURE AND GIVING BLOOD BUT THE READINGS REMAINED LOW. THE DOCTOR REPLACED THE SUSPECT FORESIGHT SENSORS WITH NEW FORESIGHT SENSORS AND THE CEREBRAL OXIMETRY WAS READING 65 BILATERALLY. NO KNOWN PATIENT HARM OR INJURY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787923 ↗
• MalfunctionNov 26, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE OBVIOUSLY HIGH READING OF ABOVE 90 WAS DISPLAYED SOON AFTER APPLYING A SET OF FORESIGHT SENSORS ON THE PATIENT'S HEAD. THE SENSORS WERE REPLACED, AND THE MEASUREMENT WAS STABLE AT AROUND 65. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784008 ↗
• MalfunctionNov 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THE FSESL FORESIGHT SENSORS READINGS WERE WITHIN NORMAL RANGE FOR 3 HOURS BUT THEN SLOWLY DRIFTED TO 55 AND 59 WHILE ASSESSING CEREBRAL OXIMETRY. INTERVENTION INCLUDED THE DOCTOR TRYING TO IMPROVE THE OXIMETRY READING BY ADJUSTING ETCO2 BLOOD PRESSURE AND GIVING BLOOD BUT THE READINGS REMAINED LOW. THE DOCTOR REPLACED THE SUSPECT FORESIGHT SENSORS WITH NEW FORESIGHT SENSORS AND THE CEREBRAL OXIMETRY WAS READING 65 BILATERALLY. NO KNOWN PATIENT HARM OR INJURY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739059 ↗
• MalfunctionJan 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE LARGE FORESIGHT SENSOR. IT STOPPED SENSING DURING AN OPEN HEART PROCEDURE. IT OCCURRED WHEN THE CLINICIANS STARTED COOLING ON CARDIOPULMONARY BYPASS. THEY COULD NOT OBTAIN A CONSISTENT READING. THE NUMBERS WOULD DROP, EVEN THOUGH THE HEMODYNAMICS WERE UNCHANGED. THE NUMBERS THAT WERE EXPECTED AND THE NUMBERS THAT DISPLAYED ARE UNKNOWN. WHEN THEY PUSHED ON THE SENSOR ON THE PATIENT FOREHEAD, THE NUMBERS RETURNED TO BASELINE. THEY EXCHANGED THE SUSPECT SENSOR FOR A DIFFERENT SENSOR. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT. THE PATIENT DEMOGRAPHICS ARE UNKNOWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531547 ↗
• MalfunctionJan 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE FORESIGHT SENSOR, LARGE. IT STOPPED SENSING DURING AN OPEN HEART PROCEDURE. IT OCCURRED WHEN THE CLINICIANS STARTED COOLING ON CARDIOPULMONARY BYPASS. THEY COULD NOT OBTAIN A CONSISTENT READING. THE NUMBERS WOULD DROP, EVEN THOUGH THE HEMODYNAMICS WERE UNCHANGED. THE NUMBERS EXPECTED AND THE NUMBERS DISPLAYED ARE UNKNOWN. WHEN THEY PUSHED ON THE SENSOR ON THE PATIENT FOREHEAD, THE NUMBERS RETURNED TO BASELINE. THEY EXCHANGED THE SUSPECT SENSOR FOR A DIFFERENT SENSOR. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT. THE PATIENT DEMOGRAPHICS ARE UNKNOWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530681 ↗
• MalfunctionJan 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A FORESIGHT SENSOR, LARGE, DURING PATIENT USE. THE USER STATES THERE WERE LOW READINGS. THE VALUE RECEIVED WAS LESS THAN 40 BILAT, WITHOUT ANY CLINICAL CORRELATION. THERE WERE NO ERROR MESSAGES. WHEN THE SENSOR WAS EXCHANGED FOR A DIFFERENT SENSOR, THERE WERE NORMAL LEVELS OBTAINED, AT 70 BILAT. THE SENSOR PLACEMENT WAS FOREHEAD LEFT AND RIGHT SIDE. PATIENT SKIN WAS PREPPED WITH ALCOHOL PRIOR TO PLACEMENT. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT PROVIDED. THERE WAS NO PATIENT HARM. THERE WERE TWO FORESIGHT LARGE SENSORS USED WITH THIS PATIENT. THE OTHER SENSOR WILL BE REPORTED UNDER A SEPARATE MDR SUBMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522502 ↗
• MalfunctionJan 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A FORESIGHT SENSOR, LARGE, DURING PATIENT USE. THE USER STATES THERE WERE LOW READINGS. THE VALUE RECEIVED WAS LESS THAN 40 BILAT, WITHOUT ANY CLINICAL CORRELATION. THERE WERE NO ERROR MESSAGES. WHEN THE SENSOR WAS EXCHANGED FOR A DIFFERENT SENSOR, THERE WERE NORMAL LEVELS OBTAINED, AT 70 BILAT. THE SENSOR PLACEMENT WAS FOREHEAD LEFT AND RIGHT SIDE. PATIENT SKIN WAS PREPPED WITH ALCOHOL PRIOR TO PLACEMENT. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT PROVIDED. THERE WAS NO PATIENT HARM. THERE WERE TWO FORESIGHT LARGE SENSORS USED WITH THIS PATIENT. THE OTHER SENSOR WILL BE REPORTED UNDER A SEPARATE MDR SUBMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143675. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2022 · Mar 1, 2022 · Open, Classified
  FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.