BioFlo DuraMax® (REF H965103028051)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884450793220), received between Mar 26, 2025 and Apr 23, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

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

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. Feb 13, 2026Open, Classified

   16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

   Z-1579-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967924 ↗
• MalfunctionApr 23, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967919 ↗
• MalfunctionApr 23, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967911 ↗
• MalfunctionApr 23, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967900 ↗
• InjuryMar 26, 2026Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT DURING DIALYSIS, AIR WAS ASPIRATED THROUGH THE DIALYSIS CATHETER. A DEFECTIVE DIALYSIS CATHETER WAS SUSPECTED WITH REPLACEMENT PLANNED AND TO PRESERVE THE EXPLANTED CATHETER FOR EXAMINATION PURPOSES. THE PATIENT HAD NO SYMPTOMS AT ANY TIME.

  Patient problems: Failure of Implant

  MAUDE report 24698212 ↗
• MalfunctionMar 12, 2026Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING DIALYSIS TREATMENT WITH A BIOFLO DURAMAX 15.5F 32 CM DUAL-VALVE SHEATH CATHETER KIT, LEAKAGE WAS OBSERVED NEAR THE LUER NECK. BLOOD LEAKAGE OCCURRED FROM THE ARTERIAL LIMB, RESULTING IN TERMINATION OF THE DIALYSIS TREATMENT. THE CATHETER WAS EXCHANGED WITH ANOTHER DEVICE. DEVICE EVALUATION CONFIRMED A FRACTURE/HOLE IN THE EXTENSION TUBING ADJACENT TO THE ARTERIAL HUB LUER. INVESTIGATION DETERMINED THE MOST LIKELY CAUSE TO BE OVER-TORQUING OF THE EXTENSION TUBING-TO-LUER HUB JUNCTION DURING CLEANING OR HANDLING. NO MANUFACTURING OR ASSEMBLY DEVIATIONS WERE IDENTIFIED IN THE DEVICE HISTORY RECORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582983 ↗
• MalfunctionSep 18, 2025Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation

  THE ACCOUNT ALLEGES THAT THE VALVED BREAKAWAY INTRODUCER FAILED TO SPLIT UPON ATTEMPTING TO REMOVE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085437 ↗
• MalfunctionJul 9, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO DURAMAX 15.5F 32CM DUAL VALVE SHEATH BASIC KIT. IT WAS REPORTED THAT THE BIOFLO DURAMAX CATHETER WAS LEAKING UNDER THE LUER NECK. DUE TO THE LEAK IN THE DIALYSIS CATHETER, BLOOD LEAKED FROM THE ARTERIAL LIMB; THE TREATMENT WAS ABORTED. THE CATHETER WAS EXCHANGED FOR ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461872 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  CUSTOMER REPORTS ONE OF THE WINGS SNAPPED TOWARDS THE TOP, NOT ALLOWING THE PHYSICIAN TO PROPERLY PEELAWAY THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704289 ↗
• InjuryMar 26, 2025Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED AN ISSUE WITH A 15CM ACUTE DIALYSIS CATHETER. THE PATIENT RETURNED DUE TO INABILITY TO DIALYZE. A PIN HOLE WAS IDENTIFIED ON ONE OF THE LUMENS WHERE THE TUBING IS CLEAR. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704288 ↗