INVOS RSC-1Recalls & reported problems
Covidien LP · Reusable Sensor Cable · Class 2
Data updated Oct 13, 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 10884521145597), received between Apr 26, 2019 and Feb 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Alarm System1
- Incorrect Measurement1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2025Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement
IT WAS REPORTED THAT DURING USE, THE DEVICE HAD AN ABNORMAL MEASUREMENT VALUES. THE RSO2 VALUE DID NOT CHANGE FROM 80%. TWO CHANNELS WERE USE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342956 ↗MalfunctionApr 26, 2019Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE DEVICE HAD A LOW READING. IT WAS REPORTED THAT READING VALUES RANGES AT 10, 20 AND 45 THEN NO READING AT ALL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8555572 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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