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Schon 10801702Recalls & reported problems

Angiodynamics, Inc. · 14F x 20cm Schon XL Double Lumen (Short Term) · Class 2 · Implant

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 H787108017020), received between Jun 9, 2017 and Jun 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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

  • Leak/Splash1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 9, 2017Leak/Splash; Leak/Splash

    AS REPORTED TO ANGIODYNAMICS ON OCTOBER 12, 2016: THE PATIENT'S CATHETER HAD A LEAK/CRACK AT THE EXTERNAL LUMEN. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6629754 ↗

Other Catheter, hemodialysis, implanted devices

All Catheter, hemodialysis, implanted devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.