StarBurst 700-101320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H7877001013201), received between Jul 31, 2018 and Jan 6, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED : THE GENERATOR PROMPTED FOR FAILURE WHEN THE ELECTRODE ENTERS THE PATIENT'S BODY. TWO (2) NEEDLES USED DURING THIS PROCEDURE HAD THE SAME ISSUE. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY AS THE PATIENT WAS SEDATED AND THE PROCEDURE WAS NOT COMPLETED; PATIENT SAFETY RISK OF UNNECESSARY SEDATION. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554843 ↗
• MalfunctionJul 31, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED TO ANGIODYNAMICS ON JULY 19, 2018: DURING AN RFA PROCEDURE, THE RFA PROBE DISPLAYED THE ERROR MESSAGE "LO" IN THE WINDOW. WHEN THE PROBE WAS WITHDRAWN, THE INSULATION LAYER OF THE PROBE SHAFT APPEARED TO BE BURNT AND DISCOLORED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY DUE TO THIS EVENT. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION AS TO THE PATIENT'S WELL-BEING IN REGARDS TO THIS EVENT. THE DEVICE INVOLVED IN THE INCIDENT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734954 ↗

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