Microstream DLPM35MN02Recalls & reported problems
Covidien LP · PM35MN, with Microstream and Nellcor SPO2 Technologies · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521786936), received between Nov 5, 2024 and Sep 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “High Readings” (2 reports).
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
- High Readings2
- Charging Problem1
- Device Alarm System1
- Failure to Calibrate1
- Image Display Error/Artifact1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Calibrate; Low Readings
It was reported that, prior to use the device was not able to calibrate and read very low at 1 to 2 percent on CO2 calibration check. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927028 ↗MalfunctionSep 28, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925886 ↗MalfunctionAug 7, 2025Device Alarm System; Image Display Error/Artifact; Charging Problem; Device Alarm System; Image Display Error/Artifact; Charging Problem
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT DID NOT CHARGE AND HAD THE ERROR MESSAGE ¿CHECK SUM ERROR¿. TROUBLESHOOTING STEPS INCLUDED POWER CYCLING THE UNIT, REPLACING THE POWER CORD, AND SWAPPING THE BATTERIES TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22741900 ↗MalfunctionNov 5, 2024High Readings; High Readings
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A HIGH CO2 READINGS. A CALIBRATION GAS WAS SPRAYED TO THE UNIT AS A TROUBLESHOOTING STEP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612588 ↗
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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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