HOFFMANN 4922-8-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540681157), received between Jan 2, 2019 and Jan 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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.

• MalfunctionJan 2, 2019Disconnection; Unstable

  THE DOCTOR REPORTED TO SALES REP THAT DUE TO THE ACCIDENTALLY FALLING DOWN OF THE PATIENT 1 MONTH AGO AFTER SURGERY, A HOFFMAN 3 PIN-HOLE CONNECTOR WAS DISCONNECTED AND THE STABILITY OF THE ASSEMBLY WAS LOST. THE PATIENT CAME TO HOSPITAL AND HOFFMAN SYSTEM WAS ADJUSTED WITH ANOTHER CONNECTORS IN ORDER TO BE RESTORED THE STABILITY.

  Patient problems: Fall

  MAUDE report 8210690 ↗