FilterflowRecalls & reported problems across all models

We found 7 models of Filterflow by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2017 and May 20, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (11 reports).

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

Most reported Filterflow problems

Filterflow models

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

• Filterflow® 473036

  Set, administration, intravascular
  9 reports
• Filterflow® 473994

  Set, administration, intravascular
  9 reports
• Filterflow® 352424

  Set, administration, intravascular
  6 reports
• Filterflow® 352205

  Set, administration, intravascular
  6 reports
• Filterflow® 473995

  Set, administration, intravascular
  3 reports
• Filterflow® 473989

  Set, administration, intravascular
  2 reports
• Filterflow® 352212

  Set, administration, intravascular
  1 report

Recent Filterflow adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: THIS COMPLAINT DOCUMENTS THE CLAIMANT'S ALLEGATION THAT THE FILTER FAILS TO EFFECTIVELY ELIMINATE AIR FROM IV TUBING, RAISING CONCERNS ABOUT COMPROMISED AIR ELIMINATION FUNCTIONALITY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231192 ↗
• MalfunctionFeb 2, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: END USER REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE FILTERED EXTENSION SET. AIR IS SOMETIMES OBSERVED IN THE FILTER; HOWEVER, BUBBLES ARE OFTEN VISIBLE ONCE THE INFUSION HAS STARTED. IT WAS REPORTED THAT THE INFUSION PUMP ALARMED FOR AIR WHEN THE ISSUE OCCURRED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231258 ↗
• MalfunctionSep 11, 2025Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE DEVICE LEAKED EVEN WHEN CLAMPED IN MULTIPLE PLACES. AFTER BEING ATTACHED TO PATIENT, BLOOD AND AIR WERE PULLED INTO LINE BEFORE FILTER. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026353 ↗
• MalfunctionSep 11, 2025Inadequate Filtration Process; Inadequate Filtration Process

  AS REPORTED BY THE USER FACILITY: AIR IS GETTING IN THE SYSTEM DURING PRIMING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025890 ↗
• MalfunctionJul 25, 2025Inadequate Filtration Process; Inadequate Filtration Process

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: SET NOT WORKING PROPERLY. DETAILED INQUIRY DESCRIPTION: (B)(6) LOCATION WAS DOING A TRIAL ON THIS FILTERED EXTENSION. THEY WERE ONLY USING IT TO FILTER OUT BUBBLES IN THE LIPIDS THEY WERE GIVEN THEIR PATIENTS. THE PRODUCT DID NOT WORK PROPERLY. IT DID NOT ELIMINATE ALL THE BUBBLES. THE TARGETED POPULATION IS VERY SMALL, AND A BUBBLE CAN CAUSE HARM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612215 ↗
• MalfunctionDec 30, 2024Inadequate Filtration Process; Inadequate Filtration Process

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: THE INLINE 1.2-MICRON IV FILTERS FOR USE WITH A IV FLUID. AFTER USING THE FILTERS, WE NOTICED THAT DESPITE IT BEING A 1.2 U FILTER, THERE WERE PARTICLES OVER 10 U AFTER FILTRATION. THEY DID A PARTICLE ASSESSMENT AND THE FOUND 10-MICRON PARTICLES IN FLUID AFTER FILTRATION DESPITE USING A 1.2 MICRON FILTER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036062 ↗
• MalfunctionOct 11, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, WE HAVE HAD COMPLAINTS FROM OUR MD'S & RN'S ABOUT THE FILTER EXT SET #473994. THIS IS INTENDED TO KEEP AIR OUT OF THE IV IN FOR INFANTS; IT IS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428815 ↗
• MalfunctionFeb 14, 2024Leak/Splash; Leak/Splash

  AS REPORTED FROM MEDWATCH (B)(4): DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS STARTED ON PACLITAXEL WITH FILTER INTACT. AFTER A FEW SECONDS OF STARTING THE PUMP, THE REGISTERED NURSE (RN) NOTICED THE CONNECTION SITE WAS LEAKING AND DOUBLE CHECKED. SHE QUICKLY NOTIFIED THE PRIMARY RN/TEAM LEAD (TL). THE BLUE DRIP-FREE CONNECTOR WAS CHANGED, AND IT WAS DETERMINED THE LEAKING WAS STILL OCCURRING AT THE FILTER SITE. LEAK WAS CONSTITUTED OF SALINE IN THE PRIMED LINE AND CAUGHT EARLY BEFORE CHEMO ACTUALLY FILLED THE TUBING. PHARMACY WAS PROMPTLY NOTIFIED. MEDICATION WAS DISCONNECTED FROM PATIENT AND SENT BACK DOWN TO PHARMACY FOR TUBE CHANGE/FILTER PRIMING. MEDICATION ARRIVED WITH NEW TUBING/NEW FILTER IN PLACE. MEDICATION WAS RESTARTED WITH 2-RN VERIFIER. CONNECTION SITE MONITORED FOR FURTHER LEAKING, AND IT WAS DETERMINED THE LEAK WAS NO LONGER PRESENT. PHARMACY NOTIFIED TO KEEP FILTER CONNECTOR FOR LOT INFO FOR INCIDENT TRACKING. EQUIPMENT PROVIDED TO DIRECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705272 ↗
• MalfunctionSep 18, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: END USER REPORTS LEAKING DURING CHEMO USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770397 ↗
• MalfunctionSep 14, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION CHEMO SPILL. CONNECTION LEAKED DOESN'T STAY ON PER RN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743928 ↗
• MalfunctionAug 25, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION - CHEMO SPILL. DETAILED INQUIRY DESCRIPTION: RN THINK IT WAS LEAKING FROM THE GREEN CONNECTION BUT COULD HAVE BEEN FROM THE CONNECTION ABOVE IT (FURTHER FROM THE PATIENT). RN CHECKED ALL CONNECTIONS BEFORE INFUSION, BUT IT STILL LEAKED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624576 ↗
• MalfunctionAug 24, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO SPILL. DETAILED INQUIRY DESCRIPTION: RN THINK IT WAS LEAKING FROM THE GREEN CONNECTION BUT COULD HAVE BEEN FROM THE CONNECTION ABOVE IT (FURTHER FROM THE PATIENT). RN CHECKED ALL CONNECTIONS BEFORE INFUSION, BUT IT STILL LEAKED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17620712 ↗
• MalfunctionAug 15, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: PER THE ACCOUNT, THE CUSTOMER REPORTS THAT THE FILTERS BOG DOWN THE PRESSURE LINES AND DO NOT ALLOW SUFFICIENT TRANSFER OF THE PRESSURE FROM THE BAGS TO COMPETE WITH THE PATIENT'S ARTERIAL SYSTEM. WHEN THE TEAM HAD PUMPED THE FLUSH LINE BAGS HALFWAY THROUGH THE CASE A LARGE BOLUS OF AIR CAME THROUGH THE LINE HEADING UP THE NEURONMAX GUIDE WHICH WAS IN THE R-TVS AT THE TIME. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548534 ↗
• MalfunctionAug 15, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: PER THE ACCOUNT, THE CUSTOMER REPORTS THAT THE FILTERS BOG DOWN THE PRESSURE LINES AND DO NOT ALLOW SUFFICIENT TRANSFER OF THE PRESSURE FROM THE BAGS TO COMPETE WITH THE PATIENT'S ARTERIAL SYSTEM. WHEN THE TEAM HAD PUMPED THE FLUSH LINE BAGS HALFWAY THROUGH THE CASE A LARGE BOLUS OF AIR CAME THROUGH THE LINE HEADING UP THE NEURONMAX GUIDE WHICH WAS IN THE R-TVS AT THE TIME. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548533 ↗
• MalfunctionFeb 1, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER REPORTS AIR BUBBLES ARE FORMING IN THE FILTER WHEN RUNNING AT LOW RATE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277489 ↗

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