StarBurst 700-103902Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H7877001039021), received between Oct 10, 2017 and Jun 10, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2020Temperature Problem; Temperature Problem

  A DISTRIBUTOR REPORTED A PATIENT ISSUE WHEN USING A STARBURST XL15CM DEVICE. AFTER SETTING UP THE UNIT AND TAPING DISPERSIVE ELECTRODES TO THE PATIENT, THE PROCEDURE WAS STARTED BY OPENING THE ANTENNA 2CM. AFTER 10 MINUTES OF RADIOFREQUENCY ABLATION (RFA) ENERGY START, THE UNIT TEMPERATURE MONITOR ONLY DISPLAYED 50-60 DEGREES CELSIUS AND TEMPERATURE NOT TO TARGET TEMPERATURE (STABLE AT 50-60 DEGREE CELSIUS FOR ALL TEMPERATURE INDICATOR, WATT DELIVERY EQUAL WATT SETTING) . THE DOCTOR REQUESTED THE MACHINE BE POWERED OFF AND BACK ON. 10 MINUTES AFTER THE MACHINE WAS RESTARTED, THE MONITORED STILL DISPLAYED 50-60 DEGREES CELSIUS FOR RFA ENERGY. THE SCRUB NURSE LOOKED AT THE PATIENT'S SKIN AND NOTICED THERE WAS EVIDENCE OF A BURN, SO THE RFA ENERGY WAS STOPPED AND THE STARBURST XL ELECTROSURGICAL DEVICE WAS REMOVED FROM THE PATIENT. THE CASE WAS ABORTED. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Burn, Thermal

  MAUDE report 10139511 ↗
• MalfunctionOct 10, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED TO ANGIODYNAMICS ON SEPTEMBER 21, 2017: DURING THE PREPARATION, IT WAS REPORTED THAT THE STARBURST XL PROBE TINES WERE DIFFICULT TO DEPLOY. THE PROBE WAS IRRIGATED/FLUSHED WITH STERILE SALINE PREPROCEDURE, AT WHICH TIME IT WAS OBSERVED THAT A DISCOLORED FLUID CAME FROM THE LINE. THE DOCTOR DETERMINED NOT TO USE ANOTHER XL NEEDLE AS A PRECAUTION DUE TO CONCERNS THE EVENT WOULD RE-OCCUR. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6935056 ↗

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-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
• 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