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CELSITE 5433823Recalls & reported problems

B Braun Interventional Systems, Inc · CELSITE ST301G ST SET SIL 10F IV USA · Class 2 · Implant

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 04046963594978), received between Jun 28, 2016 and Jun 28, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

  • Detachment Of Device Component1

Patient problems

  • Swelling1

Recent adverse event reports

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

  • InjuryJun 28, 2016Detachment Of Device Component; Detachment Of Device Component

    "THE CATHETER SEPARATED FROM THE APPLICATION DEVICE INTO THE PATIENT CAUSING THE LOCAL BULGE. THE PATIENT DIED BECAUSE HE WAS BEARER OF A DISEASE (CANCER) AND WAS IN THE TERMINAL PHASE OF THE DISEASE. THEREFORE THE FAMILY HASN'T AUTHORIZED THE REMOVAL OF THE DEVICE. EMPHASIZING THAT THE PATIENT DIDN'T CAME TO DEATH DUE TO WHAT HAPPENED TO THE PORT".

    Patient problems: Swelling

    MAUDE report 5754433 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

All PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices →

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