StarBurst 700-101930Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H7877001019301), received between Sep 25, 2018 and Jan 6, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  AS REPORTED :HI" SHOWED UP ON THE FIRST TEMPERATURE WINDOW AND "OP" SHOWED UP ON THE FIFTH TEMPERATURE WINDOW. THE VALUE OF THE SECOND, THIRD AND FOURTH TEMPERATURE WINDOW DID NOT CHANGE" . 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 9554737 ↗
• InjuryOct 15, 2019Temperature Problem; Temperature Problem

  DURING AN RFA PROCEDURE USING A STARBURST RFA PROBE, "OP" SHOWED UP ON THE FIFTH TEMPERATURE WINDOW AND COULDN'T START ABLATION. 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 9192642 ↗
• InjuryOct 15, 2019Temperature Problem; Temperature Problem

  AS REPORTED: DURING AN RFA PROCEDURE USING A STARBURST RFA PROBE, "OP" SHOWED UP ON THE FIFTH TEMPERATURE WINDOW AND COULDN'T START ABLATION. 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 9192641 ↗
• InjurySep 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING AN RFA PROCEDURE, IT WAS REPORTED THE TROCAR OF THE RFA PROBE DETACHED FORM THE SHAFT. THE PROBE WAS PLACED INSIDE OF THE PATIENT AT THE TIME OF THE EVENT. THE DETACHED TROCAR WAS STILL OUTSIDE OF THE INSERTION SITE, SO THE TREATING PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE PROBE SHAFT WITH A PAIR OF TWEEZERS. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT SUFFER ANY HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7907019 ↗

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