FORE-SIGHT ELITE® 01-06-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10609538630009), received between Oct 22, 2024 and Jun 30, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0834-2022 · Root cause: Software in the Use Environment · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING USE OF A FORESIGHT ELITE MONITOR, A 15-YEAR-OLD MALE PATIENT WAS DECLARED BRAIN DEAD FOLLOWING AN OPEN-HEART SURGERY FOR REPLACEMENT OF PULMONARY VALVE REPLACEMENT AND PFO CLOSURE. PER THE LOGS, THE FORESIGHT ELITE MONITOR DISPLAYED SIGNIFICANT DROPS IN TISSUE OXYGEN SATURATION. IT IS SUSPECTED THAT THAT THE ALARM VOLUME WAS SET TO WHISPER DURING THE CASE. THE FACILITY STATED THAT THE SURGEON WAS UNAWARE OF THE LOW TISSUE OXYGEN SATURATION (STO2) VALUES DURING THE CASE. THE FACILITY DOES NOT SUSPECT A PRODUCT MALFUNCTION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22366674 ↗
• InjuryOct 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE CUSTOMER HAS BEEN HAVING SOME ISSUES WITH FORESIGHT. THE CUSTOMER STATED THAT THEY HAVE BEEN HAVING ISSUES WITH THE SENSOR STAYING ON THE PATIENT, SEVERAL TIMES THEY HAVE NOT BEEN ABLE TO GET READINGS ON PATIENTS AND THEY HAVE ALSO SAID THAT THEY HAVE HAD ISSUES WITH NUMBERS THAT DO NOT MATCH THE PATIENTS CONDITION. THE CUSTOMER MENTIONED AN INSTANCE OF A PATIENT A FEW MONTHS AGO THAT WAS SHOWING NORMAL NUMBERS ON THE FORESIGHT BUT HAD A STROKE. IT IS UNKNOWN IF THE STROKE OCCURRED IN THE OR OR THE ICU AFTER SURGERY.

  Patient problems: Stroke/CVA

  MAUDE report 20510744 ↗