therMaxTherMax Blood Warmer 955630Recalls & reported problems
Baxter Healthcare Corporation · The TherMax blood warmer is an accessory device intended for use with the PrisMax system and appropriate blood warmer compatible Prismaflex sets for the therapy in use. The blood warmer heats the return blood flow during a PrisMax system treatment in order to replace heat lost to the atmosphere and replacement fluids. · Class 2
All models of therMaxTherMax Blood Warmer (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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412639505), received between Jun 13, 2022 and Jun 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excessive Heating” (1 report).
1 FDA recall record name this device's 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, 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.
Recalls naming this device
- Sep 19, 2019Class IITerminated
TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
Z-0247-2020 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Excessive Heating1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2022Excessive Heating; Excessive Heating
IT WAS REPORTED THAT DURING USE WITH A THERMAX BLOOD WARMER, "HEMOLYSING CELLS" WERE NOTED, SPECIFIED AS THE UNIT WAS "GETTING TOO HOT AND DAMAGING CELLS". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14680853 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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