PRISMAFLEX SET 107636USRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412954073), received between Jul 16, 2024 and Jun 29, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K212216); 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 16, 2026.

Recalls naming this device

1. Jan 6, 2026Open, Classified

   There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

   Z-1224-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH TWO (2) UNSPECIFIED TYPES OF PRISMAFLEX SETS, AN EXTERNAL FLUID LEAK WAS OBSERVED, DESCRIBED AS "THE EFFLUENT DRAINAGE LINE THAT HAD SEPARATED AT POD CAUSING THE FLUID LEAK." THE FIRST THERAPY WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. THE SET WAS REPLACED TO CONTINUE TREATMENT, AND THE SECOND SET LEAK WAS NOTED. CRRT WAS NOT RESTARTED. 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 25658073 ↗
• MalfunctionMar 30, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX ST100 SET, A "PIECE (LUER LOCK CONNECTOR) ON CRRT WAS BROKEN WHERE ANTICOAGULATION INFUSES" AND RESULTED IN THE LEAKAGE OF HEPARIN "ON THE BACKSIDE OF THE SYRINGE". THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730261 ↗
• MalfunctionJul 31, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THERE WERE "LARGE AMOUNTS OF AIR IN THE CIRCUIT" OF A PRISMAFLEX ST100 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY, WHICH RESULTED IN MULTIPLE MACHINE ALARMS. THE DEVICE WAS REPLACED TO CONTINUE TREATMENT. THE BLOOD WAS NOT 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22681378 ↗
• MalfunctionJul 31, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THERE WERE "LARGE AMOUNTS OF AIR IN THE CIRCUIT" OF A PRISMAFLEX ST100 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY, WHICH RESULTED IN MULTIPLE MACHINE ALARMS. THE DEVICE WAS REPLACED TO CONTINUE TREATMENT. THE BLOOD WAS NOT 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 22681166 ↗
• InjuryJul 16, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH PRISMAFLEX ST100 SET, THE CIRCUIT WAS FILLED WITH AIR AND NEEDED TO BE REPLACED TWO TIMES IN A ROW. THE TREATMENT WAS TERMINATED WITHOUT RETURNING THE EXTRACORPOREAL (EC) BLOOD TO THE PATIENT TWICE. NO PATIENT SYMPTOMS WERE REPORTED; HOWEVER, ALBUMIN INFUSION WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 22525552 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A PRISMAFLEX ST100 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY(CRRT). THE "RED CRRT CONNECTION COMPLETELY POPPED OFF OF THE PATIENT". THE VOLUME OF BLOOD LOSS WAS UNKNOWN. 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 21396152 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE EFFLUENT LINE AND CARTRIDGE OF PRISMAFLEX ST100 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. 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 21039864 ↗
• MalfunctionOct 24, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ACCESS LINE OF A PRISMAFLEX ST100 SET BECAME DISCONNECTED AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521171 ↗
• MalfunctionJul 16, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A FOREIGN MATERIAL CLOGGED THE FILTER AND A "RUBBER LIKE THREAD" WAS OBSERVED IN THE RETURN LINE OF A PRISMAFLEX ST100SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE SET WAS REPLACED TO CONTINUE TREATMENT. 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 19749895 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212216. One submission often covers many models, so check the product and lot details in each record.

• Z-1225-2026 · Jan 6, 2026 · Open, Classified
  PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Z-0084-2023 · Sep 14, 2022 · Open, Classified
  Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement th