therMaxTherMax Blood WarmerRecalls & reported problems across all models

We found 2 models of therMaxTherMax Blood Warmer by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2022 and Mar 2, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

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

therMaxTherMax Blood Warmer 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.

1. 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 therMaxTherMax Blood Warmer problems

therMaxTherMax Blood Warmer models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• therMaxTherMax Blood Warmer 955630

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall1 report
• therMaxTherMax Blood Warmer 955516

  Dialyzer, high permeability with or without sealed dialysate system
  11 reports

Recent therMaxTherMax Blood Warmer adverse event reports

The 12 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED AT THE CONNECTION OF A PRISMAFLEX ST150 SET AND A THERMAX BLOOD WARMER DISPOSABLE DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THE SET WAS REPLACED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489621 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LUER LOCK CONNECTION BETWEEN A PRISMAFLEX ST150 SET AND A THERMAX BLOOD WARMER DISPOSABLE WAS LOOSE AND ALLOWED BLOOD LEAKAGE DURING CONTINUOUS RENAL REPLACEMENT THERAPY, DESCRIBED AS "BLOOD WAS SPRAYED OVER THREE NURSES". THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421541 ↗
• MalfunctionJan 21, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "CONTAMINATE" WAS OBSERVED IN THE PORT TUBING OF A THERMAX BLOOD WARMER DISPOSABLE, DESCRIBED AS "CLEAR PORT HAS PAPER SHRED INSIDE". THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136367 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLOTTING WAS OBSERVED IN A THERMAX BLOOD WARMER DISPOSABLE DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAX MACHINE. IT WAS ADDITIONALLY REPORTED THAT THERE WAS A "POSSIBLE BLOOD ADMINISTRATION DUE TO FILTER LOSS". NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23597761 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT TREATMENT USING A THERMAX BLOOD WARMER, "THE CONNECTION/SNAP BETWEEN THE THERMAX BLOOD WARMER SET AND THE PRISMAFLEX SET BREAKS AND BLOOD STARTS FLOWING." TREATMENT WAS DISCONTINUED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383627 ↗
• MalfunctionSep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A BLOOD LEAK WAS OBSERVED ORIGINATING AT THE CONNECTION BETWEEN THE THERMAX BLOOD WARMER DISPOSABLE AND A PRISMAFLEX ST150 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE LEAK WAS ¿TOWARDS THE AIR SEPARATION CHAMBER". THE VOLUME OF BLOOD LOSS WAS APPROXIMATELY 200ML. 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 17817932 ↗
• MalfunctionSep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A THERMAX BLOOD WARMER DISPOSABLE. THIRTY MINUTES INTO CONTINUOUS RENAL REPLACEMENT THERAPY THE LEAK WAS OBSERVED FROM THE LUER LOCK CONNECTION BETWEEN THE THERMAX DISPOSABLE AND THE RETURN BLOOD LINE OF THE PRISMAFLEX HP-X SET. TREATMENT WAS DISCONTINUED WITHOUT BLOOD RESTITUTION AND THE ACCUMULATED BLOOD LOSS WAS 192ML. 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 17691138 ↗
• MalfunctionMay 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX MACHINE EQUIPPED WITH A THERMAX BLOOD WARMER, A MINOR EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE LUER LOCK CONNECTION BETWEEN THE THERMAX DISPOSABLE AND THE RETURN BLOOD LINE OF THE PRISMAFLEX ST150 SET, RESULTING IN A SMALL BLOOD CLOT. 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 17034099 ↗
• MalfunctionSep 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER TEN HOURS OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAFLEX ST100 SET AND A PRISMAX MACHINE EQUIPPED WITH A THERMAX BLOOD WARMER, AN EXTERNAL BLOOD LEAK (179ML) WAS OBSERVED BETWEEN THE ST100 SET POSTER FILTER LUER CONNECTION AND THE THERMAX WARMER LUER CONNECTION. 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 15378544 ↗
• 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 ↗
• MalfunctionMay 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX MACHINE EQUIPPED WITH A THERMAX BLOOD WARMER, A MINOR EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE LUER LOCK CONNECTION BETWEEN THE THERMAX DISPOSABLE AND THE RETURN BLOOD LINE OF THE PRISMAFLEX ST150 SET, RESULTING IN A SMALL BLOOD CLOT. THE TREATMENT WAS ENDED AND THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. 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 14522027 ↗
• MalfunctionJan 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED IN THE STERILE BAG TUBE OF A THERMAX BLOOD WARMER DISPOSABLE. THE PM WAS FURTHER DESCRIBED AS A ¿HAIR¿ AND WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158171 ↗

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