Filterflow® 473036Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04022495770196), received between Dec 20, 2017 and May 20, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (3 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, 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 18, 2026.

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.

• 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 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 ↗
• 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 ↗
• MalfunctionJan 3, 2023Leak/Splash; Leak/Splash

  AS MEDWATCH: DESCRIPTION: PATIENT REQUIRES FILTERS ON ALL LINES. FILTER CLOSEST, INFUSING PATIENT-CONTROLLED ANALGESIA (PCA) TO THE PATIENT, BROKE AND PATIENT HAD BLOOD BACK FLOW THROUGH THE LINE. PATIENT WAS COVERED IN BLOOD AND PCA PUMP WAS NOT INFUSING PAIN MEDICATION DUE TO THE BROKEN FILTER. INTRAVENOUS INFUSION (IV) WAS STOPPED, CLAVE WAS CHANGED, AND NEW IV TUBING WAS PLACED WITH A NEW FILTER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16091277 ↗
• MalfunctionJan 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE FILTER LEAKED CHEMO DURING USE OF PACLITAXEL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203159 ↗
• MalfunctionJul 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT: CUSTOMER HAS INDICATED CHEMOTHERAPY LEAKED THROUGH THE DEVICE DUE TO A CRACK IN THE LUER LOCK CONNECTION OF THE PRODUCT. THE PRODUCT REMAINED CONNECTED TO THE PATIENT'S CENTRAL ACCESS DEVICE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10295323 ↗
• MalfunctionFeb 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: DURING CHEMOTHERAPY WITH IFOSFAMIDE, THE FILTER WAS CONNECTED TO THE END OF THE PRIMARY ADMINISTRATION SET AND THE NEEDLE FREE VALVE/INJECTION CAP ON THE PICC LINE. THE FILTER DID NOT DISCONNECT BUT BROKE BETWEEN THE STRAIGHT PART AND THE CIRCLE OF THE FILTER. THE STRAIGHT PART OF THE FILTER REMAINED ATTACHED TO THE INJECTION CAP/VALVE AFTER IT BROKE. THE FILTER DID NOT LEAK PRIOR TO OR END OF INFUSION AND FILTER DID NOT APPEAR CRACKED. AFTER THE CHEMOTHERAPY WAS COMPLETED AND THE FLUSH WAS INFUSING, THE NURSE BELIEVES THERE WAS NO CHEMO LOSS OR LEAKAGE, BUT PRECAUTIONS WERE TAKEN JUST IN CASE. IMMEDIATE MEDICAL INTERVENTION CHEMO SPILL KIT WAS USED, PATIENT'S ARM WAS WASHED WITH SOAP AND WATER. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295660 ↗
• MalfunctionDec 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: PATIENT WAS RUNNING AROUND IN THE PLAYROOM WHICH CAUSED THE TUBING TO BE TWISTED AND THE CONNECTION TO BE OVER TORQUED, CAUSING IT TO BREAK AND BLOOD TO LEAK. THE PATIENT'S CHEMOTHERAPY WITH MANNITOL WAS COMPLETED, SO ONLY PRIMARY FLUIDS WERE RUNNING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7135366 ↗