Avoximeter Whole Blood OximeterRecalls & reported problems across all models
Accriva Diagnostics Holdings, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Avoximeter Whole Blood Oximeter by Accriva Diagnostics Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Avoximeter Whole Blood Oximeter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 27, 2024Class IICompleted
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.
Z-0279-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported Avoximeter Whole Blood Oximeter problems
Device problems
- Difficult to Insert1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Avoximeter Whole Blood Oximeter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall0 reports
- 1 report
Recent Avoximeter Whole Blood Oximeter adverse event reports
The 1 most recent reports across all models, 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 ↗
Other Accriva Diagnostics Holdings, Inc. products
All Accriva Diagnostics Holdings, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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