DuraFlow 10301201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787103012010), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).

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. How this data works · Data updated Oct 13, 2026.

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.

• 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 ↗

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-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-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
• 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-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