Skip to content

DuraFlow 10301215Recalls & reported problems

Angiodynamics, Inc. · DuraFlow 2 - 15.5F x 48cm Chronic Hemodialysis Catheter Set (with Cuff 43cm from Tip) · Class 2 · Implant

All models of DuraFlow (6)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787103012150), received between Jul 21, 2016 and Jul 21, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • 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 ↗

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-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-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-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

Other Catheter, hemodialysis, implanted devices

All Catheter, hemodialysis, implanted devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page