StarBurst Talon 700-102845Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI H7877001028451), received between Aug 31, 2017 and Oct 23, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K010060); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  BASED ON NEW INFORMATION RECEIVED, THIS COMPLAINT FILE IS BEING CANCELLED. IT WAS CONFIRMED THAT THIS COMPLAINT FILE WAS A DUPLICATE OF A PREVIOUSLY REPORTED COMPLAINT. SECTION H10 HAS THE CORRECTED COMPLAINT FILE REFERENCE. THEREFORE THIS REPORT IS BEING SUBMITTED TO CLOSE OUT THE FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987047 ↗
• MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  BASED ON NEW INFORMATION RECEIVED, THIS COMPLAINT FILE IS BEING CANCELLED. IT WAS CONFIRMED THAT THIS COMPLAINT FILE WAS A DUPLICATE OF A PREVIOUSLY REPORTED COMPLAINT. SECTION H10 HAS THE CORRECTED COMPLAINT FILE REFERENCE. THEREFORE THIS REPORT IS BEING SUBMITTED TO CLOSE OUT THE FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987045 ↗
• MalfunctionSep 18, 2023Material Deformation; Material Deformation

  DFIRST DEVICE: A CLINICAL SPECIALIST REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A TALON 25CM SEMIFLEX. THE CS RECEIVED A CALL FROM THE IR TECH REGARDING AN ISSUE WITH TWO RITA STARBURST RFA PROBES. FOR THE FIRST PROBE, THE END USER STATED THAT DURING PREPARATION, ONCE THE PROBE WAS CONNECTED AND THE SALINE TUBING WAS INSERTED INTO THE INFUSION PUMP, HE TRIED TO PRIME IT AND THE TUBING BEGAN TO BE PULLED INTO THE INFUSION PUMP. HE ALSO SAID HE NOTICED THERE WAS A KINK IN THE TUBING LINE. THE PROBE WAS CHANGED OUT FOR A SECOND PROBE. THEY TRIED PROBE NUMBER TWO AND HAD A DIFFERENT PROBLEM ((B)(6)). THEY TRIED A THIRD PROBE AND WERE ABLE TO SUCCESSFULLY TREAT THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE CASE WAS DELAYED APPROXIMATELY 45 MINUTES TO 1 HOUR. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK DUE TO PROLONGED PROCEDURE GREATER THAN 30 MINUTES (EXTENDED SEDATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765987 ↗
• MalfunctionSep 18, 2023Leak/Splash; Leak/Splash

  SECOND DEVICE: A CLINICAL SPECIALIST REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A TALON 25CM SEMIFLEX. THE CS RECEIVED A CALL FROM THE IR TECH REGARDING AN ISSUE WITH TWO RITA STARBURST RFA PROBES. AFTER THE INITIAL PREP OF DEVICE ONE WHERE THE INFUSION TUBING WAS PULLED INTO THE INFUSION PUMP, ((B)(6)), THEY SWITCHED IT OUR FOR A SECOND PROBE. UPON OPENING THE SECOND DEVICE IT WAS ATTACHED AND THE INFUSION TUBING PUT INTO PLACE. UPON PRIMING SALINE BEGAN TO "SQUIRT" FROM THE TUBING FROM THE LITTLE WHITE DISC ON THE SIDE OF THE TUBING WHERE THE WHITE SEPARATION TAB IS. THE COMPLAINANT STATED IT WAS BROKEN UPON OPENING. HE ALSO STATED HE TRIED TO FIX IT BACK ONTO THE TUBING BUT AT PRIMING AGAIN SPEWED SALINE.THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE CASE WAS DELAYED APPROXIMATELY 45 MINUTES TO 1 HOUR. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK DUE TO PROLONGED PROCEDURE GREATER THAN 30 MINUTES (EXTENDED SEDATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765986 ↗
• MalfunctionJul 28, 2022Fracture; Fracture

  A DISTRIBUTOR REPORTED AN ISSUE WITH A TALON 25CM PROBE. DURING AN RFA PROCEDURE, USING A TALON 25CM PROBE, THE MANIFOLD. WATER PIPE JOINT WAS FOUND TO BE DETACHED FROM THE TUBING. IT WAS ALSO NOTED THE SHAFT SLEEVE HAD SEPARATED WHILE INSIDE THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW OF THE SAME AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120900 ↗
• MalfunctionMar 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH A TALON 25CM SEMIFLEX PROBE. DURING AN RFA OF THE LIVER, WHEN THE TALON PROBE WAS PLACED, IT WAS REPORTED THERE WAS NO RESISTANCE WHEN ENTERING THE LESION. IN THE FIRST TWO "SALES", THERE WAS NO RESISTANCE WHEN OPENING THE TIP. THE PROVIDER NEEDED TO CHANGE POSITIONS, SO WITHDREW THE PROBE, AT WHICH TIME IT WAS NOTICED THE TIP OF THE PROBE WAS MISSING. IT WAS SUSPECTED THE TIP WAS RETAINED INSIDE THE PATIENT, SO THE PROVIDER FIRST "OPENED/DISSECTED" THE PROBE SHAFT WITH A TOOL, WHERE THEY FOUND THE NEEDLE/TIP WAS IN THE NEEDLE TUBE/PROBE TUBE. IT WAS ALSO REPORTED THAT THE PROBE HAD DISPLAYED "OP" SHOWED ON THE NUMBER 1 TEMPERATURE WINDOW. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840071 ↗
• MalfunctionSep 23, 2020Fracture; Fracture

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN ISSUE WITH A TALON 25CM SEMIFLEX PROBE. DURING A PROCEDURE, THE DOCTOR NOTED THAT THE PATIENT'S TUMOR WAS VERY FIBROTIC, WITH GREAT RESISTANCE TO NEEDLE PENETRATION. THE NEEDLE STEMS OPENED NORMALLY IN THE FIRST ABLATION SESSION. HOWEVER, DURING THE SECOND SESSION, THE DOCTOR BELIEVES, WITH THE TISSUE BEING HARD, AN INVERSE TENSION MAY HAVE OCCURRED WHEN OPENING THE NEEDLE WITH IT CURVED, AND THIS BROKE THE PROTECTION THAT COVERS THE NEEDLE. IT WAS REPORTED THE PATIENT WAS TREATED IN A FOLLOWUP PROCEDURE WITH NO ISSUES. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10572543 ↗
• MalfunctionMay 11, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6), 2018: DURING A RADIO FREQUENCY ABLATION PROCEDURE, THE GENERATOR DIDN'T WORK AND SHOWED OP ON THE DISPLAY WHEN THE PROBE WAS PLACED INTO THE TARGET ZONE. THE TREATING PHYSICIAN RETRACTED THE ARRAY OF ELECTRODES AND WITHDREW THE DEVICE. ONCE THE PROBE HAD BEEN WITHDRAWN IT WAS NOTED 2 OF THE TINES HAD DETACHED AND DROPPED INTO THE BODY OF THE PROBE. THE PATIENT WAS NOT IMPACTED DUE TO THIS EVENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7506219 ↗
• MalfunctionAug 31, 2017Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING A CT GUIDED LIVER ABLATION PROCEDURE, WHEN WITHDRAWING THE PROBE IN ORDER TO PLACE FOR A SECOND ABLATION, IT WAS NOTED THE SHAFT OF THE PROBE HAD BENT AND CRACKED OPEN. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. 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 6833593 ↗
• MalfunctionAug 31, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: IT FOUND THAT PROBES COULD NOT BE DEPLOYED FOR WITHDRAWING 3CM BACK FOR RE-ABLATION, AFTER ONE COMPLETE ABLATION. CONNECTION MISTAKE WAS DISPLAYED ON GENERATOR,PULL OUT THE ELECTRODE, AND FOUND ONE OF PROBE TIP WAS BROKEN. TIP DID NOT BREAK OFF INSIDE OF THE PATIENT, PATIENT DID NOT SUFFER ANY HARM OR INJURY. 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 6833583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010060. One submission often covers many models, so check the product and lot details in each record.

• Z-0411-2020 · Oct 2, 2019 · Terminated
  Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
• Z-0887-06 · May 2, 2006 · Terminated
  Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-
• Z-0888-06 · May 2, 2006 · Terminated
  XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length