MasimoSET Red LNC-10 LNCS® Patient Cable 2056Recalls & reported problems
Masimo Corporation · MasimoSET Red LNC-10 LNCS Patient Cable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843997001267), received between Apr 10, 2019 and Oct 5, 2023 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Low Readings1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathOct 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
PER THE MAUDE DATABASE- GE HEALTHCARE BECAME AWARE OF A PATIENT DEATH WHICH INVOLVED ANOTHER MANUFACTURER'S PRODUCT. A MASIMO SPO2 CABLE WAS IDENTIFIED AS HAVING BEEN INVOLVED WITH A PATIENT DEATH IN 2022.
Patient problems: Insufficient Information
MAUDE report 17882816 ↗MalfunctionApr 10, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED THE SPO2 VALUES WOULD BEGIN READING OK THEN, WOULD SUDDENLY DROP INTO THE 60S AND 70S. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8502169 ↗
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- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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