PRISMAFLEX SET M60Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07332414064549), received between Mar 21, 2018 and Aug 6, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

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

6 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.

Recalls naming this device

1. 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

Recent adverse event reports

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

• MalfunctionAug 6, 2026Obstruction of Flow

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160442 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO USE, A LEAK WAS OBSERVED AT THE "GREEN LINE" OF A PRISMAFLEX M60 SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645625 ↗
• MalfunctionApr 26, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE "PRESSURE BYPASS VALVE" OF A PRISMAFLEX M60 SET WAS BROKEN AND LEAKING DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193429 ↗
• MalfunctionMay 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM THE AIR CHAMBER OF A PRISMAFLEX M60 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894767 ↗
• MalfunctionSep 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FEW MINUTES AFTER STARTING THERAPY, ONE UNIT OF PRISMAFLEX M60 SET HAD A BLOOD LEAK AT THE RETURN LINE UP NEAR THE RETURN / VENOUS CLAMP AND JUST BELOW THAT AREA. THE AMOUNT OF BLOOD LOSS WAS ESTIMATED TO BE AROUND 200ML. THERE WAS PATIENT INVOLVEMENT HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412830 ↗
• MalfunctionMar 29, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING WITH ONE UNIT OF PRISMAFLEX M60 SET, A CRACK WAS OBSERVED IN THE DE-AERATION CHAMBER AND FLUID LEAKED OUT RESULTING IN AN UNSPECIFIED ALARM BEING TRIGGERED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939265 ↗
• MalfunctionSep 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE TOP AREA OF THE DIALYZER ON A PRISMAFLEX M60 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519180 ↗
• MalfunctionJul 20, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TEN MINUTES INTO TREATMENT WITH A PRISMAFLEX M60 SET , A BLOOD LEAK AT THE JUNCTION AFTER BLOOD PUMP TUBE WAS OBSERVED. BLOOD WAS RETURNED TO THE PATIENT AND THEY WERE DISCONNECTED AND TREATMENT ENDED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707742 ↗
• MalfunctionMar 21, 2018Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT A PRISMAFLEX M60 SET CLOTTED DURING USE, AND BLOOD LEAKED FROM THE PBP TUBING. THE FILTER CLOTTED AT THE PBP LINE, WHERE IT WRAPS AROUND THE BLOOD PUMP. AFTER THE SET CLOTTED, THE REPORTER NOTICED A LEAK FROM WHAT APPEARED TO BE A TINY PIN HOLE IN THE TUBING. TREATMENT WAS STOPPED AND THE PATIENT WAS DISCONNECTED. THE BLOOD IN THE CIRCUIT WAS NOT RETURNED TO THE PATIENT. THE PATIENT HAD MINIMAL BLOOD LOSS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7360091 ↗

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-1227-2026 · Jan 6, 2026 · Open, Classified
  PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Z-2378-2021 · Jul 22, 2021 · Terminated
  Baxter 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 · Terminated
  Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Z-2202-2014 · Jul 18, 2014 · Terminated
  Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Z-0695-2007 · Jan 4, 2007 · Terminated
  Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
• Z-0032-2007 · May 16, 2006 · Terminated
  Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.