Nellcor MAXARRecalls & reported problems

Covidien LP · Adult SpO2 Sensor Remanufactured;Reprocessed device for single use. Reprocessed by Covidien llc. · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884522040102), received between May 13, 2025 and May 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Therapeutic or Diagnostic Output Failure1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 13, 2025Therapeutic or Diagnostic Output Failure
PROBES FAILED TO WORK WITH ALERT "NO PROBE" ALARMING ON MONITOR SCREEN. ATTEMPTED EXCHANGING BLUE CABLE, BLOWING OUT DUST FROM CABLE PLUG HOLES ON THE BRICK, UNPLUGGING AND RE-PLUGGING THE BRICK FROM MONITOR. ALL THESE INTERVENTIONS FAILED.
Patient problems: Insufficient Information
MAUDE report 22008485 ↗

Device details

UDI-DI	`20884522040102`
Brand	Nellcor
Model	MAXAR
Company	Covidien LP
Product code	NLF · OXIMETER, REPROCESSED
Class	Class 2
FDA submission	K033973
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 16, 2026

Device type (GMDN): Pulse oximeter probe, reprocessed

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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All OXIMETER, REPROCESSED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.