DuraMaxRecalls & reported problems across all models

We found 8 models of DuraMax by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between May 18, 2016 and Jun 22, 2023 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DuraMax recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1773-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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 DuraMax problems

DuraMax models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DuraMax 10302803

  Catheter, hemodialysis, implanted
  1 recall10 reports
• DuraMax 10302804

  Catheter, hemodialysis, implanted
  1 recall4 reports
• DuraMax 10302820

  Catheter, hemodialysis, implanted
  1 recall1 report
• DuraMax 10302818

  Catheter, hemodialysis, implanted
  3 reports
• DuraMax 10302819

  Catheter, hemodialysis, implanted
  2 reports
• DuraMax 10302809

  Catheter, hemodialysis, implanted
  1 report
• DuraMax 10302822

  Catheter, hemodialysis, implanted
  1 report
• DuraMax 10302824

  Catheter, hemodialysis, implanted
  1 report

Recent DuraMax adverse event reports

The 15 most recent reports across all models, 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 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 16771265 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Angiodynamics, Inc. products

• Soft-Vu54 models · 66 reports · 18 recalls
• Mini Stick MAX12 models · 2 reports · 12 recalls
• Smart Port CT36 models · 479 reports
• VenaCure EVLT15 models · 437 reports
• AccuVu9 models · 14 reports · 4 recalls
• Solero4 models · 154 reports
• DuraFlow6 models · 8 reports · 2 recalls
• NanoKnife9 models · 44 reports · 1 recall