DuraMax 10302803Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI H787103028030), received between May 18, 2016 and Apr 19, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1766-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 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 16771270 ↗
• 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 16771268 ↗
• 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 16771264 ↗
• 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 16771263 ↗
• 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 16771262 ↗
• 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 16771260 ↗
• MalfunctionJul 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG. DURING A PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS COMING OFF THE TUNNELER. THE WHITE BOOT THAT SLIDES OVER CATHETER, TO LOCK IN PLACE, WAS LOOSE AND THE CATHETER SLIPPED THROUGH IT AND OFF THE TUNNELER. THE CLINICIAN HAD TO REMOVE THE WHITE BOOT FROM INSIDE THE PATIENT. THE CLINICIAN WAS ABLE TO REATTACH THE CATHETER TO THE TUNNELER AND PROCEEDED TO FINISH THE PROCEDURE WITH ALL THE SAME DEVICE AND ACCESSORIES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206951 ↗
• InjuryDec 30, 2019No Flow; No Flow

  AS REPORTED FROM ANGIODYNAMICS SAUDI ARABIA DISTRIBUTOR' CUSTOMER TO THE DISTRIBUTOR: I HAD A PATIENT WHO WAS REFERRED FROM A NEPHROLOGIST ABOUT TWO MONTHS AGO FOR A PERM-A-CATH INSERTION (USING ANGIODYNAMICS' DURAMAX DIALYSIS CATHETER). THE PROCEDURE WAS SMOOTH AND A RIGHT IJV PERM-A-CATH WAS SITED AT IDEAL POSITION AT JUNCTION BETWEEN SVC AND RIGHT ATRIUM. AFTER INSERTION SHE WENT HOME WITHOUT DOING DIALYSIS SESSION. AFTER TWO DAYS OF INSERTION SHE CAME TO THE HOSPITAL TO DO HD SESSION BUT UNFORTUNATELY THERE WAS RESISTANCE IN BLOOD FLOW DENOTING THROMBOSIS. AFTER TRIAL BY THE NEPHROLOGIST TO IMPROVE THE FLOW BY HEPARIN INJECTION INTO THE CATHETER, THE FLOW IMPROVED PARTIALLY AND STILL NOT PERFECT AND EVERY TIME SHE COME FOR HD THEY KEEP TRYING TO IMPROVE THE FLOW BY HEPARIN UNTIL THE NEPHROLOGIST DECIDED TO EXCHANGE THE CATHETER. I DID THE CATHETER EXCHANGE TWO WEEKS AGO OVER A WIRE AND A LARGE CLOT WAS NOTED FILLING THE CATHETER TIP AND PROTRUDING OUTSIDE THE CATHETER. THE NEPHROLOGIST ASKED ABOUT HEPARIN ADMINISTRATION AND I INFORMED HIM THAT TO GIVE HEPARIN SAFELY AS NO INCISIONS OR SKIN MANIPULATIONS WAS DONE SO NO FEAR FROM OOZING, AND THE PATIENT DID HD SESSION WELL. IT WA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9530387 ↗
• MalfunctionNov 29, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING A DIALYSIS PROCEDURE, THE DURAMAX CATHETER FRACTURED DURING INSERTION. THE CATHETER BROKE-OFF ABOUT AN INCH BELOW THE HUB WHILE THE TREATING PHYSICIAN WAS SUTURING THE CATHETER IN PLACE. THE CATHETER WAS REMOVED AND SET ASIDE. HE REPEATED THE PROCEDURE WITH ANOTHER DURAMAX CATHETER WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT. THE REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8116818 ↗
• InjuryMay 18, 2016Break; Device Issue; Break; Device Issue

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR A DIALYSIS PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE DIALYSIS CATHETER INTO THE PATIENT VIA THE SHEATH. WHILE ADVANCING THE CATHETER AND ATTEMPTING TO TEAR AWAY THE PEELABLE SHEATH, THE SHEATH TORE APART INTO SEVERAL PIECES. SOME OF THE PIECES REMAINED INSIDE OF THE PATIENT. THE PHYSICIAN HAD TO OPEN THE PATIENT TO REMOVE THE REMAINING PIECES OF THE SHEATH. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5664399 ↗

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-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-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-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-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-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-0732-2012 · Dec 30, 2011 · Terminated
  Angiodynamics DuraMax 24 cm STRAIGHT --- 1-15.5F x 24cm DuraMax Hemodialysis Catheter (with Cuff 19cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302903 --- MANUFACTURED I
• 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-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-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-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-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

…and 14 more.