DuraFlowRecalls & reported problems across all models

We found 6 models of DuraFlow by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jul 21, 2016 and Apr 3, 2023 — classified as 2 deaths, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

DuraFlow 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-1763-2024 · 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-1761-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported DuraFlow problems

DuraFlow models

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

• DuraFlow 10301202

  Catheter, hemodialysis, implanted
  1 recall1 report
• DuraFlow 10301211

  Catheter, hemodialysis, implanted
  1 recall0 reports
• DuraFlow 10301203

  Catheter, hemodialysis, implanted
  2 deaths4 reports
• DuraFlow 10301201

  Catheter, hemodialysis, implanted
  1 report
• DuraFlow 10301215

  Catheter, hemodialysis, implanted
  1 report
• DuraFlow 10301219

  Catheter, hemodialysis, implanted
  1 report

Recent DuraFlow adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PEELABLE SHEATH FROM A DURAFLOW 2 PROCEDURE KIT. THE USER REPORTED THAT WHEN THEY BROKE OPEN THE SHEATH, 4 VERY SHARP "TOOTH LIKE" PROJECTIONS ARE LEFT BEHIND THAT HAVE ACTUALLY CUT OPEN THE USER'S GLOVE DURING CATHETER INSERTION. THE PROJECTIONS DID NOT BREAK THE PROVIDER'S SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662509 ↗
• DeathFeb 6, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A PATIENT ISSUE THAT OCCURRED DURING A PROCEDURE IN WHICH A DURAFLOW 2, 32CM STRAIGHT BASIC KIT WAS USED. A PATIENT WAS IN FOR A DIALYSIS CATHETER EXCHANGE (TEMP CATHETER TO A PERM CATHETER). A GUIDEWIRE WAS INSERTED INTO A LUMEN OF THE ORIGINAL TEMP CATHETER TO MAINTAIN ACCESS AND THE CATHETER WAS REMOVED. DILATORS FROM THE DURAFLOW 2 KIT (ITEM H787103012030) WERE USED TO DILATE THE VESSEL AND THE EMBOSAFE INTRODUCER SHEATH WAS THEN USED. THE FIRST ATTEMPT TO ADVANCE THE EMBOSAFE DILATOR SHEATH WAS UNSUCCESSFUL IN ADVANCING DUE TO FIBROTIC TISSUE. THERE WAS NO DEVICE MALFUNCTION, AND IT WAS REPORTED THE SHEATH WAS UNABLE TO BE REUSED AS IT HAD BECOME BENT DURING THE ATTEMPTS TO INSERT AND ADVANCE. ANOTHER KIT (ITEM H787103012010) WAS OPENED SO A NEW EMBOSAFE COULD BE USED. THE SECOND ATTEMPT WAS ALSO UNSUCCESSFUL, HOWEVER, AFTER THE PHYSICIAN PULLED IT OUT, THE SHEATH WAS "SCRUNCHED" UP ABOUT HALFWAY UP THE DILATOR. THE PHYSICIAN DETERMINED THERE WAS A LOT OF FIBROTIC/SCAR TISSUE IN THE PATIENT FROM PREVIOUS ACCESS INTO THE SITE. A TELEFLEX DIALYSIS KIT WAS OPENED AND A THIRD ATTEMPT WAS MADE WHERE THERE WAS STILL LOTS OF RESISTANCE, BUT WAS SUCCESSFULLY INTRODUCED. THE PHYSICIAN

  Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16303228 ↗
• MalfunctionJan 28, 2022Fracture; Fracture

  AN OR MANAGER REPORTED AN ISSUE WITH A DURAFLOW 2, 28CM STRAIGHT BASIC KIT. DURING A LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER INSERTION PROCEDURE, THE SURGEON ATTEMPTED TO PULL THE GUIDEWIRE OUT OF THE VESSEL AND WAS MET WITH RESISTANCE DUE TO A KINK. WHEN THE GUIDEWIRE WAS PULLED OUT, IT BECAME UNRAVELLED AND A PIECE FELL OFF INSIDE OF THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW KIT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. TO NOTE, THE SURGEON WAS LATER INFORMED BY AN ANGIODYNAMICS REP THAT THIS DEVICE IS FOR HEMODIALYSIS USE ONLY, NOT PERITONEAL DIALYSIS.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385468 ↗
• MalfunctionJun 9, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A DURAFLOW DIALYSIS CATHETER. DURING PROCEDURE CLOSURE, THE TUNNELER SHEATH [SLEEVE] BROKE OFF INTO A PATIENT. THE SHEATH WAS SUCCESSFULLY REMOVED WITH NO PATIENT IMPACT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968679 ↗
• DeathSep 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  USER MEDWATCH REPORT (B)(4) RECEIVED FROM END USER FACILITY ((B)(6)) ON 28-AUG-2019 VIA HARDCOPY MAIL. PATIENT HAD A DURAFLOW DIALYSIS CATHETER IMPLANTED ON (B)(6) 2014 AND WAS RECEIVING DIALYSIS TREATMENT ON (B)(6) 2019. PT. ATTENDED REGULARLY SCHEDULED DIALYSIS TREATMENT. PRE-TREATMENT VITAL SIGNS WERE: WEIGHT (B)(6) KG, BLOOD PRESSURE 148/57, PULSE 72, RESPIRATION 18, TEMP. 96.8. TREATMENT STARTED AT 0623 VIA RIGHT INTERNAL JUGULAR CATHETER AT AN ORDERED BLOOD FLOW RATE OF 400ML/MIN. HEMACLIP ATTACHED TO VENOUS LINE. AT APPROXIMATELY 0718, STAFF MEMBER NOTED BLOOD ON THE FLOOR, TREATMENT CHAIR, AND PATIENT'S SHIRT. STAFF REPORTED THE BLUE HUB OF THE CATHETER HAD DISCONNECTED FROM THE LUMEN OF THE CATHETER. HEMASAFE CLIP REMAINED ATTACHED TO THE BLOOD LINE. PATIENT WAS NON-RESPONSIVE. SALINE BOLUS GIVEN THROUGH RED HUB OF CATHETER. CPR STARTED AND 911 CALLED. PER STAFF REPORTS, AS EMS TRANSFERRED THE PATIENT FROM THE TREATMENT CHAIR TO THE STRETCHER, THE RED HUB ALSO DETACHED FROM THE CATHETER LUMEN. NO ADDITIONAL BLOOD LOSS WAS EXPERIENCED BY THE PATIENT, AS THE CATHETER LUMEN WAS CLAMPED, PT. TRANSFERRED TO LOCAL HOSPITAL. PATIENT EXPIRED IN THE EMERGENCY DEPARTMENT AT 0815.

  Patient problems: Death; Exsanguination

  MAUDE report 9128885 ↗
• InjuryJul 6, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  PER USER MEDWATCH MW5068034, RECEIVED ON MARCH 10, 2017: PATIENT HAD A TUNNELED IJ HEMODIALYSIS CATHETER ON (B)(6) 2013. THE PATIENT WAS SCHEDULED TO HAVE IT REMOVED. UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE CUFF WAS RETAINED INSIDE THE PATIENT. AN EXPERT PHYSICIAN WAS CONTACTED FOR ASSISTANCE. SHE WAS UNABLE TO LOCATE THE CUFF AND IT WAS DECIDED THAT ATTEMPTING TO LOCATE/REMOVE IT WOULD CAUSE MORE DAMAGE THAN LEAVING IT IN. THE PATIENT WAS LATER DISCHARGED WITH INFORMATION AND INSTRUCTIONS RELATED TO THE RETAINED CUFF. THE EVENT DID NOT RESULT IN PROLONGED HOSPITALIZATION OR INJURY TO THE PATIENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 6690059 ↗
• InjuryApr 6, 2017Detachment Of Device Component; Detachment Of Device Component

  PER USER MEDWATCH MW5068034, RECEIVED ON MARCH 10, 2017: PATIENT HAD A TUNNELED IJ HEMODIALYSIS CATHETER ON (B)(6) 2013. THE PATIENT WAS SCHEDULED TO HAVE IT REMOVED. UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE CUFF WAS RETAINED INSIDE THE PATIENT. AN EXPERT PHYSICIAN WAS CONTACTED FOR ASSISTANCE. SHE WAS UNABLE TO LOCATE THE CUFF AND IT WAS DECIDED THAT ATTEMPTING TO LOCATE/REMOVE IT WOULD CAUSE MORE DAMAGE THAN LEAVING IT IN. THE PATIENT WAS LATER DISCHARGED WITH INFORMATION AND INSTRUCTIONS RELATED TO THE RETAINED CUFF. THE EVENT DID NOT RESULT IN PROLONGED HOSPITALIZATION OR INJURY TO THE PATIENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6463256 ↗
• InjuryJul 21, 2016Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR A CATHETER PLACEMENT. DURING THE PROCEDURE, WHILE THE TREATING PHYSICIAN WAS PLACING THE DIALYSIS CATHETER IN THE PATIENT'S GROIN, THE HANDLES OF THE VALVED SHEATH INTRODUCER BROKE OFF. AS A RESULT OF THE FRACTURE, 2 PIECES OF THE SHEATH WERE LEFT IN PATIENT'S VEIN IN THE GROIN. THE FRACTURED PIECES WERE REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5811754 ↗

Other Angiodynamics, Inc. products

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• Smart Port CT36 models · 479 reports
• VenaCure EVLT15 models · 437 reports
• AccuVu9 models · 14 reports · 4 recalls
• DuraMax8 models · 23 reports · 3 recalls
• Solero4 models · 154 reports
• NanoKnife9 models · 44 reports · 1 recall