PRISMAFLEX SET M100Recalls & reported problems
Gambro Industries · The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Prismaflex M100 set is a tubing set for continuous kidney replacement therapy. Its 151 adverse event reports include 4 injuries and 1 death; many describe fluid leaking from the set, plus cracks and breaks. Its 2 recalls, both open, concern a part that may detach from the control unit and an Estonian instruction translation error about patient weight limits.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 150
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 07332414064556), received between Jul 3, 2018 and Aug 11, 2026 — classified as 1 death, 4 injuries, 145 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (120 reports).
2 FDA recall records name this device's identifier, 2 still open.
5 other recalls cover devices cleared under the same FDA submission (K041005); 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
Recalls naming this device
- Jan 6, 2026Open, Classified
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1227-2026 · Root cause: Component design/selection · FDA record ↗
- Sep 14, 2022Open, Classified
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Z-0081-2023 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak120
- Crack17
- Break15
- Leak/Splash11
- Detachment of Device or Device Component5
- Air/Gas in Device4
- Loose or Intermittent Connection4
- Disconnection3
Patient problems
- No Clinical Signs, Symptoms or Conditions112
- No Consequences Or Impact To Patient24
- No Patient Involvement8
- Asystole2
- Blood Loss2
- Air Embolism1
- Bradycardia1
- Death1
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Fluid/Blood Leak; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210942 ↗MalfunctionJun 22, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE EFFLUENT BAG OF A PRISMAFLEX M100 SET APPROXIMATELY THIRTY MINUTES AFTER THE START OF CONTINUOUS RENAL REPLACEMENT THERAPY. THE BAG 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 25580108 ↗MalfunctionJun 9, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE REPLACEMENT LINE OF A PRISMAFLEX M100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447456 ↗MalfunctionApr 30, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING PRIMING WITH A PRISMAFLEX M100 SET, AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE BLUE CONNECTOR BETWEEN THE SET AND THE WARMER EXTENSION LINE . THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050182 ↗MalfunctionMar 13, 2026Fluid/Blood Leak; Air/Gas in Device
IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX M100 SET, THERE WAS "LEAKAGE AT PRE-BLOOD PUMP LINE AS AIR BUBBLES WERE SEEN ALONG THE LINE". 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 24591721 ↗MalfunctionMar 13, 2026Fluid/Blood Leak; Air/Gas in Device
IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX M100 SET, THERE WAS "LEAKAGE AT PRE-BLOOD PUMP LINE AS AIR BUBBLES WERE SEEN ALONG THE LINE". 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 24590443 ↗MalfunctionMar 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE PRESSURE SENSOR OF A PRISMAFLEX M100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24520460 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE DRAIN BAG OF A PRISMAFLEX M100 SET APPROXIMATELY FOUR (4) HOURS AFTER THE START OF CONTINUOUS RENAL REPLACEMENT THERAPY. THE "WATER WAS DRIPPING FROM THE CONNECTION BETWEEN BAG AND DRAINAGE PORT". 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 24501180 ↗MalfunctionFeb 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE DRAIN BAG OF A PRISMAFLEX M100 SET APPROXIMATELY THREE (3) HOURS AFTER THE START OF 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 24236320 ↗MalfunctionJan 14, 2026Break; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE ACCESS POD OF A PRISMAFLEX M100 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 24072651 ↗MalfunctionJan 7, 2026Break; Material Separation
IT WAS REPORTED THAT DURING PRIMING WITH A PRISMAFLEX M100 SET, "THE CARTRIDGE IN THE SET WAS BROKEN AND SEPARATED FROM THE PRE-FILTER". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23993128 ↗MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE REPLACEMENT LINE OF A PRISMAFLEX M100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882938 ↗MalfunctionDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE "POST FILTER" OF A PRISMAFLEX M100 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 23778906 ↗MalfunctionDec 9, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE DEAERATION CHAMBER OF A PRISMAFLEX M100 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. 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 23758807 ↗MalfunctionDec 4, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE FILTER CONNECTOR OF A PRISMAFLEX M100 SET WAS OBSERVED TO BE CRACKED AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715511 ↗MalfunctionNov 25, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT PRIOR TO USE, A CRACK WAS NOTICED AT THE "POST FILTER" OF PRISMAFLEX M100 AND "LIQUID WAS LEAKING OUT". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645373 ↗MalfunctionNov 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE DRAIN BAG OF A PRISMAFLEX M100 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 23605474 ↗MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE ACCESS POD OF A PRISMAFLEX M100 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 23576096 ↗MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE "POST-FILTER" OF A PRISMAFLEX M100 SET WAS OBSERVED TO BE CRACKED AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536570 ↗MalfunctionSep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE TOP OF THE FILTER "IN BETWEEN THE PLASTIC OF THE FILTER AND THE RETURN LINE TUBING" OF A PRISMAFLEX M100 SET DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22998791 ↗MalfunctionAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE ACCESS LINE OF A PRISMAFLEX M100 SET WAS OBSERVED TO HAVE A LOOSE CONNECTION AT THE FILTER AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22886382 ↗MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE EFFLUENT LINE OF A PRISMAFLEX M100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815199 ↗MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE PRESSURE POD OF A PRISMAFLEX M100 SET APPROXIMATELY ONE (1) HOUR AFTER THE START OF 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 22771760 ↗MalfunctionAug 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT IS REPORTED THAT THE FILTER CONNECTOR OF A PRISMAFLEX M100 SET WAS OBSERVED TO BE CRACKED AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720367 ↗MalfunctionAug 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE REPLACEMENT LINE OF A PRISMAFLEX M100 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 22688221 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041005. One submission often covers many models, so check the product and lot details in each record.
- Z-2378-2021 · Jul 22, 2021 · TerminatedBaxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 1
- Z-2201-2014 · Jul 18, 2014 · TerminatedPrismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2202-2014 · Jul 18, 2014 · TerminatedPrismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-0695-2007 · Jan 4, 2007 · TerminatedGambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
- Z-0032-2007 · May 16, 2006 · TerminatedGambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
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 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page