DuraMax 10302804Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787103028040), received between Jan 31, 2023 and Jun 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 reports).

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

29 other recalls cover devices cleared under the same FDA submission (K101843); 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. Mar 18, 2024Open, Classified

   Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

   Z-1768-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN END USER EXPERIENCED WITH A CATHETER FROM A DURAMAX STACKED TIP 28CM STR. BASIC KIT. WHEN THE PATIENT PRESENTED FOR A DIALYSIS TREATMENT USING THE IMPLANTED CATHETER, THE PROVIDER WAS UNABLE TO PERFORM DIALYSIS AS THE CLAMP KINKED THE CATHETER AND DIALYSIS WAS UNABLE TO BE RUN. THE PATIENT HAD TO RETURN TO THE HOSPITAL TO HAVE THE CATHETER REPLACED. ONCE REPLACED, THE PATIENT WAS ABLE TO RETURN TO THE DIALYSIS CENTER AND HAVE THE FULL TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184940 ↗
• MalfunctionJun 22, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN END USER EXPERIENCED WITH A CATHETER FROM A DURAMAX STACKED TIP 28CM STR. BASIC KIT. WHEN THE PATIENT PRESENTED FOR A DIALYSIS TREATMENT USING THE IMPLANTED CATHETER, THE PROVIDER WAS UNABLE TO PERFORM DIALYSIS AS THE CLAMP KINKED THE CATHETER AND DIALYSIS WAS UNABLE TO BE RUN. THE PATIENT HAD TO RETURN TO THE HOSPITAL TO HAVE THE CATHETER REPLACED. ONCE REPLACED, THE PATIENT WAS ABLE TO RETURN TO THE DIALYSIS CENTER AND HAVE THE FULL TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184930 ↗
• MalfunctionApr 19, 2023Fracture; Fracture

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH SEVERAL DURAMAX CATHETERS. PER THE USER, THEY HAVE RECENTLY HAD EIGHT INCIDENTS OF BROKEN CLAMPS OF PERMACATH CATHETERS. ALL INCIDENTS OCCURRED WITH THE SAME SCENARIO. THE CLAMPS WERE BROKEN OUTSIDE THE PATIENTS RESULTING IN THE CATHETER HAVING TO BE REMOVED AND REPLACED. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THESE INCIDENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771259 ↗
• MalfunctionJan 31, 2023Infusion or Flow Problem; Infusion or Flow Problem

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A CATHETER FROM A DURAMAX STACKED TIP 28CM STR. BASIC KIT. IT WAS REPORTED THE CATHETER'S BLUE PORT HAD A SLOW FLOW AND RESISTANCE. AS IT WAS INDICATED THE DEVICE IS AVAILABLE FOR RETURN, IT IS REASONABLE TO CONCLUDE THE CATHETER WAS REMOVED DUE TO THIS ISSUE. IT IS UNKNOWN IF IT WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273418 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101843. One submission often covers many models, so check the product and lot details in each record.

• Z-1578-2026 · Feb 13, 2026 · Open, Classified
  DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A,
• Z-1767-2024 · Mar 18, 2024 · Open, Classified
  DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
• Z-1766-2024 · Mar 18, 2024 · Open, Classified
  DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
• Z-1770-2024 · Mar 18, 2024 · Open, Classified
  DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
• Z-1773-2024 · Mar 18, 2024 · Open, Classified
  DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
• Z-1769-2024 · Mar 18, 2024 · Open, Classified
  DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
• Z-1771-2024 · Mar 18, 2024 · Open, Classified
  DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
• Z-1772-2024 · Mar 18, 2024 · Open, Classified
  DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
• Z-0731-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 22 cm STRAIGHT --- 1-15.5F x 22cm DuraMax Hemodialysis Catheter (with Cuff 17cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302902 --- MANUFACTURED I
• Z-0727-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 28cm Chronic Hemodialysis VascPak (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302819 --- MANUFACTURED IN USA AngioDynami
• Z-0719-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 15.5F x 22 cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip) --- Catalog No. [REF] 10302802 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Quee
• Z-0721-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302804 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Quee
• Z-0733-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302909 --- MANUFACTURED I
• Z-0729-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 40cm Chronic Hemodialysis VascPak (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302822 --- MANUFACTURED IN USA AngioDynami
• Z-0720-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 15.5F x 24 cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip) --- Catalog No. [REF] 10302803 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Quee

…and 14 more.