MaxBlend2 R229P01-001Recalls & reported problems
Maxtec, LLC · MaxBlend2 Low Flow Bird Blender DISS Fitting · Class 2
Data updated Oct 13, 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 00853061006043), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON 30TH MAY 2024, MAXTEC LLC RECEIVED AN EMAIL FROM (B)(6) OF (B)(6). BELOW IS HIS WRITE UP IN QUOTATIONS, WE HAVE RECEIVED NO FURTHER INFORMATION FROM THE COMPLAINANT EVEN AFTER MULTIPLE FOLLOW UPS. OTHER THAN THEM MENTIONING IT IS A MAXTEC BLENDER, WE ARE NOT AWARE OF THE PARTICULAR DEVICE IN QUESTION. NO FURTHER INVESTIGATION COULD TAKE PLACE AS A RESULT. "GC03833005 PLEASE REVIEW BLENDER BLENDER STOPPED WORKING WHILE ON AN ECMO PATIENT. SWEEP WAS SET AT 2 LPM AND A PRE AND POST WAS CONDUCTED AT THE BEGINNING OF THE SHIFT YIELDING GOOD RESULTS. 3 HOURS LATER PATIENT BEGAN TO DE-SAT WITH THE SAME SETTINGS. BLENDER WAS INCREASED TO 5 LPM TO YIELD A AVO2 DIFFERENCE. THERE WAS NO CONNECTION ALARM. THE GAS LINE WAS REMOVED TO CONFIRM ADEQUATE GAS FLOW. THE CONNECTIONS WERE TIGHT WITH NO GAS LEAKAGE."
Patient problems: Low Oxygen Saturation
MAUDE report 21859764 ↗
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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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