DuraFlow 10301202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787103012020), received between Jan 28, 2022 and Jan 28, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

5 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. How this data works · Data updated Oct 13, 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-1761-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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-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-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