DuraMax 10302818Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787103028180), received between Apr 23, 2021 and May 7, 2022 — classified as 1 injury, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2022Fracture; Fracture

  AN IR SUPERVISOR REPORTED AN ISSUE WITH A 24CM DURAMAX DIALYSIS CATHETER. DURING A PLACEMENT PROCEDURE, THE INTRODUCER SHEATH BROKE IN HALF WHEN THE PA WAS ATTEMPTING TO PEEL THE SHEATH AWAY. THIS OCCURRED WHILE A PORTION OF THE CATHETER WAS INSIDE OF THE PATIENT. THE CATHETER WAS REMOVED WITH THE BROKEN INTRODUCER SHEATH AND A NEW INTRODUCER SHEATH WAS USED WITH THE SAME CATHETER TO COMPLETE THE PROCEDURE. POST-PROCEDURE, IMMEDIATELY FOLLOWING INSERTION OF THE CATHETER, THE PATIENT SUFFERED A STROKE; THEREFORE, THE HOSPITAL STROKE TEAM WAS ACTIVATED AND THE PATIENT WAS SENT TO CT FOR IMAGING. THE CAUSE OF THE STROKE WAS FOUND TO BE AN AIR EMBOLISM AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT IN A BARIATRIC CHAMBER. THE LATEST UPDATE THE TEAM RECEIVED STATED THAT THE PATIENT IS IN STABLE CONDITION AND THE STROKE IS BELIEVED TO BE A DIRECT RESULT OF THE PRODUCT MALFUNCTION.

  Patient problems: Air Embolism; Foreign Body In Patient

  MAUDE report 14315089 ↗
• MalfunctionSep 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER RECEIVED A REPORT FROM AN END USER REGARDING A DURAMAX STACKED TIP 24 CM STRAIGHT VASC-PAK DEVICE. IT WAS REPORTED DURING A TUNNELED DIALYSIS CATHETER PLACEMENT, HALF OF THE HEMOSTATIC VALVE ON A PEEL-AWAY SHEATH POPPED OFF. THE WIRE AND INNER DILATOR WERE WITHDRAWN FROM PATIENT AND THE CATHETER WAS PLACED INTO THE PEELAWAY SHEATH. WHEN THE PEELAWAY WAS "POPPED", 1/2 OF THE VALVE CAME OFF. THE TREATING PHYSICIAN WAS NOT AWARE OF IT UNTIL SHE HEARD A SUCKING NOISE FROM THE SHEATH AND JUGULAR VEIN AREA. THE PHYSICIAN WAS CONCERNED AS AIR COULD HAVE BEEN SUCKED INTO THE VASCULAR SYSTEM. THE PHYSICIAN COMPLETED THE PROCEDURE MANUALLY AND AS QUICKLY AS POSSIBLE SO NO ADDITIONAL PRODUCT WAS OPENED TO ASSIST IN COMPLETING THE PROCEDURE. THE PATIENT WAS MONITORED VIA VITALS FOR ANY INDICATION OF AIR ASPIRATION, BUT NO ABNORMALITIES WERE NOTED. IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE ANY HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495049 ↗
• 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 11715379 ↗

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-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-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-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-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-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-0730-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302824 --- MANUFACTURED IN USA AngioDynami
• 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-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-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-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-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

…and 15 more.