FORE-SIGHT ELITE® 01-07-1101Recalls & reported problems
Cas Medical Systems, Inc. · Tissue Oximeter Sensor Small · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10609538711012), received between May 15, 2017 and Dec 20, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Erythema2
- Swelling1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem
A PATIENT THAT HAD OPEN HEART SURGERY WAS RECOVERING WHEN, AFTER 48 HOURS OF CEREBRAL OXIMETRY MONITORING, THE SENSOR SITE WAS CHECKED TO FIND REDNESS AND SWELLING ON THE FOREHEAD AND UNDER THE APPLICATION SITE.
Patient problems: Erythema; Swelling
MAUDE report 7134101 ↗InjuryMay 15, 2017Use of Device Problem
A NEONATE PATIENT WAS FOUND WITH RED MARKS ON THE FOREHEAD AFTER A SMALL STO2 SENSOR WAS REMOVED FOR AN APPLICATION SITE CHECK OR SENSOR REMOVAL. THE USE OF THE SENSOR WAS NOT CONSISTENT WITH THE USER DIRECTIONS AND MAY HAVE BEEN UN-CHECKED FOR AN EXTENDED PERIOD OF TIME. THIS WAS A MINOR INCIDENT AND THE CLINICIANS, INCLUDING A SKIN WOUND SPECIALIST, WERE NOT OVERLY CONCERNED ABOUT THE OUTCOME. THERE IS NO RECORD OF MEDICAL INTERVENTION AND A SERIES OF PHOTOGRAPHS 2-3 DAYS APART SHOW IMPROVEMENT.
Patient problems: Erythema
MAUDE report 6566258 ↗
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, ClassifiedFORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Other Oximeter, Tissue Saturation devices
- INVOS PMAC71RSCCovidien LP · Oximeter, tissue saturation1 recall67 reports
- HEMOSPHERE FORESIGHT MODULE HEMFSM10Edwards Lifesciences LLC · Oximeter, Tissue Saturation1 recall12 reports
- INVOS PMAC71RICCovidien LP · Oximeter, tissue saturation1 recall4 reports
- FORE-SIGHT ELITE® 01-06-3000Cas Medical Systems, Inc. · Oximeter, Tissue Saturation1 recall1 death2 reports
- Invos 5100C-EUCovidien LP · Oximeter, tissue saturation22 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation21 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation18 reports
- INVOS 5100C-PACovidien LP · Oximeter, tissue saturation15 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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