PRISMAFLEX SET 107643USRecalls & reported problems
Gambro Industries · Disposable extracorporeal circuit · Class 2
- 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 00085412954103), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT EXTERNAL FLUID AND BLOOD LEAKS WERE OBSERVED FROM THE "ANTICOAGULATION PIGTAIL" OF THREE (3) PRISMAFLEX ST60 SETS. THE LEAKAGE WAS NOTED ONCE DURING PRIMING AND THREE (3) TIMES DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THE SETS WERE REPLACED TO CONTINUE TREATMENT. 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 21416099 ↗
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-1224-2026 · Jan 6, 2026 · Open, ClassifiedPRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Z-1225-2026 · Jan 6, 2026 · Open, ClassifiedPRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Z-0084-2023 · Sep 14, 2022 · Open, ClassifiedPrismaflex 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
Other Dialyzer, high permeability with or without sealed dialysate system devices
- Optiflux® 0500318EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall6 deaths2,849 reports
- 2008® Series Hemodialysis Machines 190713Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls37 deaths893 reports
- 2008T BlueStar Hemodialysis Machine 191126Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system5 recalls10 deaths441 reports
- 2008® Series Hemodialysis Machines 190766Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls15 deaths370 reports
- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
- 2008® Series Hemodialysis Machines 190610Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall15 deaths335 reports
- Optiflux® 0500320EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system2 recalls242 reports
- REVACLEAR 300Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls125 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.