Megadyne 4000JRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10614559105764), received between Oct 17, 2018 and Oct 17, 2018 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A CRANIOTOMY ON A PATIENT AND AFTER THE PROCEDURE, THE PATIENT RETURNED WITH AN INFECTION. IT WAS NOT REPORTED HOW THE INFECTION WAS TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 7975982 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A CRANIOTOMY ON A PATIENT AND AFTER THE PROCEDURE, THE PATIENT RETURNED WITH AN INFECTION. IT WAS NOT REPORTED HOW THE INFECTION WAS TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 7975951 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A CRANIOTOMY ON A PATIENT AND AFTER THE PROCEDURE, THE PATIENT RETURNED WITH AN INFECTION. IT WAS NOT REPORTED HOW THE INFECTION WAS TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 7975898 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A CRANIOTOMY ON A PATIENT AND AFTER THE PROCEDURE, THE PATIENT RETURNED WITH AN INFECTION. IT WAS NOT REPORTED HOW THE INFECTION WAS TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 7975873 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A CRANIOTOMY ON A PATIENT AND AFTER THE PROCEDURE, THE PATIENT RETURNED WITH AN INFECTION. IT WAS NOT REPORTED HOW THE INFECTION WAS TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 7975819 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information

  IT WAS REPORTED BY THE DIVISIONAL MANAGER THAT THE DOCTOR PERFORMED A CRANIOTOMY ON A PATIENT AND AFTER THE PROCEDURE, THE PATIENT RETURNED WITH AN INFECTION. IT WAS NOT REPORTED HOW THE INFECTION WAS TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 7975815 ↗