Nellcor FLEXMAX-PRecalls & reported problems
Covidien LP · Flexible SpO2 Sensor, Reusable Small · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521532311), received between Aug 22, 2018 and Aug 27, 2018 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Low Readings” (9 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.
Most reported problems
Device problems
- Low Readings9
Patient problems
- No Consequences Or Impact To Patient9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7818979 ↗MalfunctionAug 27, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7818977 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807180 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807176 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807175 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807174 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807172 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807171 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807121 ↗
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- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
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- 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 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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