DuraMax 10302819Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787103028190), received between Apr 23, 2021 and Apr 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2021Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT THIS FACILITY IS HAVING SEVERAL ISSUES WITH ALL SIZES OF THEIR DURAMAX CATHETERS. DURING A PROCEDURE, THE TUNNELER OF THIS STACKED TIP 55CM STRAIGHT VASC-PAK, BROKE OFF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT; HOWEVER, EXTRA TIME WAS REQUIRED TO TRY AND ADVANCE THE SHEATH. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715382 ↗
• MalfunctionApr 23, 2021Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT THIS FACILITY IS HAVING SEVERAL ISSUES WITH ALL SIZES OF THEIR DURAMAX CATHETERS. DURING A PROCEDURE, THE TUNNELER OF THIS STACKED TIP 55CM STRAIGHT VASC-PAK, BROKE OFF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT; HOWEVER, EXTRA TIME WAS REQUIRED TO TRY AND ADVANCE THE SHEATH. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715377 ↗

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-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-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-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-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-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-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-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-0726-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 24cm Chronic Hemodialysis VascPak (with Cuff 19cm from Tip) --- Catalog No. [REF] 10302818 --- 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
• 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-0718-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302805 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Quee
• Z-0722-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm from Tip) --- Catalog No. [REF] 10302806 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Quee
• 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

…and 15 more.