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DuraFlow 10301219Recalls & reported problems

Angiodynamics, Inc. · DuraFlow 2 - 15.5F x 28cm Chronic Hemodialysis VascPak Kit (with Cuff 23cm from Tip) · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787103012190), received between Jun 9, 2021 and Jun 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • 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 ↗

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-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-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-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

Other Catheter, hemodialysis, implanted devices

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Sources and updates

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