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DuraMax 10302809Recalls & reported problems

Angiodynamics, Inc. · 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip) · Class 2 · Implant

All models of DuraMax (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787103028090), received between Apr 19, 2023 and Apr 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

30 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • 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 16771265 ↗

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-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-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-1768-2024 · Mar 18, 2024 · Open, Classified
    DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
  • Z-1766-2024 · Mar 18, 2024 · Open, Classified
    DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
  • 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-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-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-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-0724-2012 · Dec 30, 2011 · Terminated
    Angiodynamics DuraMax 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302809 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queen
  • 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-0728-2012 · Dec 30, 2011 · Terminated
    Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 32cm Chronic Hemodialysis VascPak (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302820 --- MANUFACTURED IN USA AngioDynami
  • Z-0723-2012 · Dec 30, 2011 · Terminated
    Angiodynamics DuraMax 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302807 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queen
  • 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-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

…and 15 more.

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Sources and updates

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