StarBurst 700-103903Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H7877001039031), received between Nov 1, 2022 and Nov 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Firing 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 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.

• MalfunctionNov 1, 2022Firing Problem; Firing Problem

  DEVICE 2 OF 2 ASSOCIATED WITH THIS EVENT: AN END USER REPORTED AN ISSUE WITH A STARBURST XL 10CM LONG PROBE. PER THE TREATING PHYSICIAN'S ACCOUNT OF THE EVENT: USING CT IMAGE GUIDANCE, A JAMSHIDI WAS ADVANCED THROUGH THE OVERLYING SKIN AND CORTEX AND USED TO BIOPSY THE OSTEOID OSTEOMA. A RITA STARBURST XL DEVICE ADVANCED THROUGH THE TRACT INTO THE PATIENT'S OSTEOID OSTEOMA AND ITS ARRAYS WERE DEPLOYED IN THE LESION. THE STARBURST NEEDLE WAS CONNECTED TO THE RITA 1500X ELECTROSURGICAL RADIOFREQUENCY GENERATOR AND THE FOLLOWING SETTINGS WERE ENTERED: TARGET TEMPERATURE: 90'C. POWER: 50WTIME: 6 MINUTES. THE DEVICE WORKED FOR A MOMENT UNTIL POWER REACHED 6W, AT WHICH TIME THE FOLLOWING ERROR MESSAGE APPEARED ON THE GENERATOR: SYSTEM FAILURE 3. TURN POWER OFF. THE GENERATOR WAS REBOOTED, AND THE SAME ERROR MESSAGE OCCURRED AFTER POWER REACHED 6W. THE NEEDLE WAS CONNECTED TO A SECOND GENERATOR, AT WHICH TIME THE FOLLOWING ERROR MESSAGE APPEARED ON THE GENERATOR: UNRECOGNIZED DEVICE. THE NEEDLE WAS CONNECTED TO THE FIRST GENERATOR AND MULTIPLE ADDITIONAL TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING REPOSITIONING THE GROUNDING PADS ON THE PATIENT AND MANIPULATING THE NEEDLE AND ARRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707768 ↗

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