StarBurst Talon 700-102847Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI H7877001028471), received between May 17, 2017 and May 2, 2019 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  WHEN OPENING THE STERILE PACKAGING OF A TALON PROBE FOR AN RFA PROCEDURE, IT WAS NOTED ONE OF THE TINES WAS DETACHED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575009 ↗
• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ANGIODYNAMICS' DISTRIBUTOR RECEIVED A COMPLAINT FROM A CUSTOMER REPORTING A TINE DETACHMENT WITH A TALON RFA PROBE. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THERE WAS NO REPORT OF ANY PATIENT EFFECT 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 Consequences Or Impact To Patient

  MAUDE report 8286813 ↗
• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ANGIODYNAMICS' DISTRIBUTOR RECEIVED A COMPLAINT FROM A CUSTOMER REPORTING A TINE DETACHMENT WITH A TALON RFA PROBE. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THERE WAS NO REPORT OF ANY PATIENT EFFECT 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 Consequences Or Impact To Patient

  MAUDE report 8286811 ↗
• MalfunctionJul 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON JULY 18, 2018: DURING AN RFA PROCEDURE, THE TREATING PHYSICIAN ABLATED THE FIRST TARGETED AREA. WHEN REPOSITIONING THE RFA PROBE IN ORDER TO ABLATE A DIFFERENT TARGET AREA, ONE OF THE PROBE TINES FRACTURED OFF. THE TINE FRACTURED OFF OUTSIDE OF THE PATIENT. THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING A NEW OF THE SAME DEVICE. THE PATIENT EXPERIENCED NO HARM OR INJURY 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 Consequences Or Impact To Patient

  MAUDE report 7734943 ↗
• MalfunctionJun 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6), 2018. ONE TINE WAS BROKEN DURING PROCEDURE. NO ANY ADVERSE FURTHER FEEDBACK ON PATIENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569821 ↗
• MalfunctionMay 11, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING A RADIOFREQUENCY ABLATION PROCEDURE, THE TINE OF THE TALON PROBE DETACHED. THE TINE DETACHED OUTSIDE OF THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT 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 7506221 ↗
• MalfunctionFeb 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING PREPARATION FOR AN RFA PROCEDURE, WHEN OPENING THE STERILE PACKAGE, IT WAS NOTED ONE OF THE TINES OF THE RFA PROBE HAD DETACHED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7247633 ↗
• MalfunctionFeb 7, 2018Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON JANUARY 23, 2018: DURING PREPARATION FOR AN RFA PROCEDURE, ONE OF THE NEEDLES (TINE) OF THE TALON PROBE DETACHED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. 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 7247628 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING AN RFA PROCEDURE, ONE OF THE TINES OF THE PROBE DETACHED. THE DETACHMENT OCCURRED OUTSIDE OF THE PATIENT. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068003 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE. THE CASE WAS AN OPEN SURGERY ABLATION. THE SALES REP OF THE COMPANY WAS INFORMED AND CALLED FOR THE CASE AS AN EMERGENCY NEED. THE DISPERSIVE ELECTRODES WERE PLACED BY THE OPERATION ROOM TECHNICIAN AS THE PATIENT WAS UNDER ANESTHESIA AND COVERED BY STERILE DRAPES. THE SALES REP DIDN'T HAVE THE CHANCE TO CHECK THE CORRECT PLACEMENT OF THE DISPERSIVE ELECTRODES. DURING THE PREPARATION, THE OPERATION ROOM STAFF OBSERVED THAT 2 OUT OF 4 INFUSION LINES OF THE TALON APPLICATOR DIDN'T INFUSE SALINE. THE APPLICATOR WAS CHANGED WITH A SAME TYPE OF TALON. DURING PREPARATION WITH THE NEW TALON PROBE, IT WAS OBSERVED THAT THE TEMPERATURE SENSORS OF DISPERSIVE ELECTRODES DIDN'T WORK PROPERLY. THE TEMPERATURE SENSOR CABLE WAS DISCONNECTED AND THE MAXIMUM POWER WAS SET UP TO 150WATTS. AFTER THE SECOND ABLATION CYCLE ON THE SECOND DEVICE, 2 OUT OF 4 INFUSION LINES OF THE APPLICATOR DIDN'T INFUSE SALINE. THE CASE WAS FINISHED BY THIS DEVICE WITHOUT PROPER SALINE INFUSION. AFTER THE CASE, A SEVERE

  Patient problems: Burn(s)

  MAUDE report 6935057 ↗
• MalfunctionMay 17, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON APRIL 18, 2017: DURING AN RFA PROCEDURE THE ELECTROSURGICAL DEVICE LOST ONE TERMOPAR WHICH REMAINED INSIDE THE TROCAR. NO PIECE OF THE DEVICE REMAINED INSIDE OF THE PATIENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572949 ↗

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-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
• 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-