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StarBurst 700-103905Recalls & reported problems

Navilyst Medical, Inc. · RITA StarBurst Electrosurgical Device · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 H7877001039051), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Temperature Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K992693); they may or may not involve this specific model.

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

Device problems

  • Temperature Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

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

  • InjurySep 25, 2018Temperature Problem; Temperature Problem

    AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: THE 15CM RITA STARBURST ELECTROSURGICAL DEVICE WITH PRE-ATTACHED CABLE WAS USED FOR A BONE OSTEOID OSTEOMA IN THE TIBIA. SUPERFICIAL LESION. DURING THE PROCEDURE THE DOCTOR OBSERVED HEAT TRAVELING UP THE DEVICE SHAFT. HE THEN STOPPED THE RF ENERGY, APPLIED ICE AND CONTINUED THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETE, THE PHYSICIAN REMOVED THE DEVICE. THE PHYSICIAN OBSERVED A SMALL BURN CLOSE TO THE SKIN AT THE ENTRY POINT OF THE DEVICE. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: Burn(s)

    MAUDE report 7907022 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992693. One submission often covers many models, so check the product and lot details in each record.

  • Z-1143-2015 · Dec 19, 2014 · Terminated
    Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No.
  • Z-0754-2007 · Apr 3, 2007 · Terminated
    RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
  • Z-0752-2007 · Apr 3, 2007 · Terminated
    RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

Other ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page