DuraMax® (REF H787103028185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884450786178), received between Jul 2, 2025 and Mar 30, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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-1578-2026 · Root cause: Process control · 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.

• InjuryMar 30, 2026Break

  CUSTOMER REPORTS THE SHEATH BROKE AT THE WRONG LOCATION; PHYSICIAN HAD TO RETRIEVE IT FROM WITHIN THE PATIENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735053 ↗
• MalfunctionMar 23, 2026Separation Failure

  THE CUSTOMER REPORTS THAT THE SHEATH DID NOT PEEL AND BROKE. THERE WAS NO PATIENT INJURY AND THE REST OF CATHETER WAS SUCCESSFULLY PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670106 ↗
• InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER-RELATED INFECTION. THESE INFECTIONS NECESSITATED EARLY CATHETER REMOVAL. THE INCIDENCE RATE OF CRI IN THE DM GROUP WAS 1.14 EVENTS PER 1,000 CATHETER DAYS, WHICH WAS NOTABLY HIGHER THAN THE COMPARATOR GROUP'S RATE OF 0.67 EVENTS PER 1,000 CATHETER DAYS. ALL CATHETERS WERE IMPLANTED WITHOUT PROCEDURAL COMPLICATIONS. THIS REPORT IS BEING SUBMITTED AS A SERIOUS INJURY DUE TO THE NEED FOR MEDICAL INTERVENTION AND EARLY DEVICE REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 22384400 ↗
• InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER-RELATED INFECTION. THESE INFECTIONS NECESSITATED EARLY CATHETER REMOVAL. THE INCIDENCE RATE OF CRI IN THE DM GROUP WAS 1.14 EVENTS PER 1,000 CATHETER DAYS, WHICH WAS NOTABLY HIGHER THAN THE COMPARATOR GROUP'S RATE OF 0.67 EVENTS PER 1,000 CATHETER DAYS. ALL CATHETERS WERE IMPLANTED WITHOUT PROCEDURAL COMPLICATIONS. THIS REPORT IS BEING SUBMITTED AS A SERIOUS INJURY DUE TO THE NEED FOR MEDICAL INTERVENTION AND EARLY DEVICE REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 22384398 ↗
• InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER-RELATED INFECTION. THESE INFECTIONS NECESSITATED EARLY CATHETER REMOVAL. THE INCIDENCE RATE OF CRI IN THE DM GROUP WAS 1.14 EVENTS PER 1,000 CATHETER DAYS, WHICH WAS NOTABLY HIGHER THAN THE COMPARATOR GROUP'S RATE OF 0.67 EVENTS PER 1,000 CATHETER DAYS. ALL CATHETERS WERE IMPLANTED WITHOUT PROCEDURAL COMPLICATIONS. THIS REPORT IS BEING SUBMITTED AS A SERIOUS INJURY DUE TO THE NEED FOR MEDICAL INTERVENTION AND EARLY DEVICE REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 22384396 ↗
• InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration

  IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384393 ↗
• InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration

  IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384392 ↗
• InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration

  IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384384 ↗
• InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration

  IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384381 ↗