StarBurst 700-102486Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H7877001024861), received between Oct 15, 2019 and Oct 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 18, 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.

• InjuryOct 15, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING AN RFA PROCEDURE USING A STARBURST RFA PROBE, ONE TINE COULDN'T BE DEPLOYED WHILE THE ELECTRODE WAS INSIDE THE TUMOR. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. AS THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS UNNECESSARILY SEDATED, THIS EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT. IT WAS INDICATED THE PATIENT DID NOT SUFFER ANY HARM OR INJURY DUE TO THE EVENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192640 ↗