Chemosite 120089Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521099289), received between Apr 12, 2016 and Apr 12, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 12, 2016Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  ACCORDING TO THE REPORTER, DURING A PORT IMPLANTATION, THE SHEATH FRACTURED. PROBLEM WAS DISCOVERED PRIOR TO USE. DEVICE WAS NOT USED ON THE PATIENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5569588 ↗