HEMOSPHERE FORESIGHT MODULE HEMFSM10Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00690103208573), received between Nov 5, 2024 and Sep 28, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (8 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 1, 2022Open, Classified

   The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

   Z-0835-2022 · Root cause: Software in the Use Environment · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923064 ↗
• MalfunctionJan 9, 2026Incorrect Measurement

  AS REPORTED, DURING A DEMO USE, THE STO2 (TISSUE OXYGEN SATURATION) CHANNELS OF THIS HEMOSPHERE FORESIGHT MODULE WERE EXCHANGED; CHANNEL 1 WAS LABELLED AS 2 AND THE CHANNEL 2 WAS LABELED AS 1. THEREFORE, IN THE MONITOR STO2 (A2) VALUES CORRESPONDED TO THE SENSOR CONNECTED IN CHANNEL 1, AND VICE VERSA. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019200 ↗
• MalfunctionJan 6, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE HEMOSPHERE FORESIGHT MODULE WAS GIVING LOW VALUES. THE CABLE WAS REPLACED, AND THE REPORTED ISSUE WAS RESOLVED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979824 ↗
• MalfunctionNov 26, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, THE HEMOSPHERE FORESIGHT ELITE MONITOR DISPLAYED LOW STO2 READINGS. THE CABLE WAS REPLACED WITH A NEW ONE, WHICH RESOLVED THE ISSUE. IT HAS BEEN CONFIRMED THAT NO PATIENT INJURY OR HARM OCCURRED IN CONNECTION WITH THIS EVENT. THE AFFECTED CABLE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659261 ↗
• MalfunctionSep 8, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, THIS HEMOSPHERE FORESIGHT CABLE PROVIDED STO2 (TISSUE OXIMETRY SATURATION) DRIFTING VALUES ON ONE SIDE OF PATIENT. THE VALUES DRIFTED BETWEEN 60 AND 90 IN ONE MINUTE. THE OTHER SIDE PROVIDED STABLE VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991033 ↗
• MalfunctionSep 8, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, THIS HEMOSPHERE FORESIGHT CABLE PROVIDED STO2 (TISSUE OXIMETRY SATURATION) DRIFTING VALUES ON ONE SIDE OF PATIENT. THE VALUES DRIFTED BETWEEN 60 AND 90 IN ONE MINUTE. THE OTHER SIDE PROVIDE STABLE VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990955 ↗
• MalfunctionSep 8, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, THIS HEMOSPHERE FORESIGHT CABLE PROVIDED STO2 (TISSUE OXIMETRY SATURATION) DRIFTING VALUES ON ONE SIDE OF PATIENT. THE VALUES DRIFTED BETWEEN 60 AND 90 IN ONE MINUTE. THE OTHER SIDE PROVIDED STABLE VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990845 ↗
• MalfunctionJun 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE FORESIGHT MODULE, IT WAS DISPLAYING STO2 VALUES THAT WERE HIGHER THAN EXPECTED. THE CLINICIAN CHANGED SENSORS, THE CABLE, AND SENSOR PLACEMENT BUT WAS UNABLE TO RESOLVE THE ISSUE. A NEW MODULE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136577 ↗
• MalfunctionMar 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THERE WAS A DISCREPANCY IN VALUES WITH THE FORESIGHT MODULE. WHEN A SENSOR WAS CONNECTED TO CHANNEL 1, THE NUMBERS RECEIVED WERE IN THE 70S AS EXPECTED. THE REP SWITCHED THE SENSOR TO CHANNEL 2 AND RECEIVED NUMBERS IN THE 30S. WHEN THEY RECOGNIZED THE DISCREPANCY, THEY PERFORMED TROUBLESHOOTING AND EXCHANGED OUT THE MODULE WHICH RESOLVED THE ISSUE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED NOR ANY PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710459 ↗
• MalfunctionMar 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE HEMOSPHERE FORESIGHT MODULE DISPLAYED INACCURATE VALUES. THE EXPECTED VALUES ARE TYPICALLY IN THE 55-65 RANGE. THE VALUES DISPLAYED WOULD DIP DOWN TO THE 35-45 BUT ONLY ON THE PATIENT'S RIGHT SIDE. THE CUSTOMER CHANGED THE DISPOSABLE FORESIGHT SENSORS STICKIES AND EXPERIENCED THE SAME ISSUE. WHEN THE HEMOSPHERE FORESIGHT MODULE WAS REPLACED, THE ISSUE RESOLVED. THERE WERE NO ERROR MESSAGES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619689 ↗
• MalfunctionNov 27, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THIS HEMOSPHERE FORESIGHT MODULE (FSM) DID NOT MEASURE PROPERLY, THE VALUES DISPLAYED WERE NOT AS EXPECTED ACCORDING TO THE PHYSIOLOGICAL STATUS OF THE PATIENT. THE EXACT VALUES DISPLAYED COULD NOT BE CONFIRMED. THE ISSUE WAS ISOLATED TO THE FSM AFTER CONNECTING SAME SENSORS TO DIFFERENT MODULE AND CORRECT VALUES WERE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795057 ↗
• MalfunctionNov 5, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR), WITH A PATIENT IN BYPASS (NON-PULSATILE MODE), OF THIS ALTA MONITOR, THE FORESIGHT CABLE CONNECTED TO THE LEFT FORESIGHT SENSOR PLACED ON THE BRAIN PROVIDED HIGHER VALUES THAN THE RIGHT-SIDE SENSOR. THE FORESIGHT CABLE WAS CHANGED AND THE ISSUE WAS SOLVED. NO ERROR MESSAGES WERE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20607840 ↗