Avoximeter Whole Blood Oximeter C100BRecalls & reported problems
Accriva Diagnostics Holdings, Inc. · Avoximeter 1000E Cuvettes 100 cuvettes/box · Class 2
All models of Avoximeter Whole Blood Oximeter (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10711234160022), received between May 2, 2019 and May 2, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K922075); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Difficult to Insert1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2019Difficult to Insert; Physical Resistance/Sticking
WHEN ATTEMPTING TO CHECK HEMOGLOBIN DURING CARDIAC CATH UNABLE TO INSERT BLOOD INTO CUVETTE. NURSE MET RESISTANCE SO CUVETTE WAS UNUSABLE MANUFACTURER RESPONSE FOR CUVETTE- WHOLE BLOOD OXIMETER, AVOX (PER SITE REPORTER). CREDITED ACCOUNT FOR 2 BOXES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8572613 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K922075. One submission often covers many models, so check the product and lot details in each record.
- Z-0279-2025 · Sep 27, 2024 · CompletedAVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
- Z-1238-2008 · Feb 13, 2008 · TerminatedInternational Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220
- Z-1237-2008 · Feb 13, 2008 · TerminatedInternational Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- 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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