DuraFlow 10301203Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787103012030), received between Apr 6, 2017 and Feb 6, 2023 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K110936); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110936. One submission often covers many models, so check the product and lot details in each record.

• Z-1765-2024 · Mar 18, 2024 · Open, Classified
  DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
• Z-1760-2024 · Mar 18, 2024 · Open, Classified
  DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
• Z-1763-2024 · Mar 18, 2024 · Open, Classified
  DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
• Z-1764-2024 · Mar 18, 2024 · Open, Classified
  DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
• Z-1762-2024 · Mar 18, 2024 · Open, Classified
  DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
• Z-1761-2024 · Mar 18, 2024 · Open, Classified
  DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021