StarBurst TalonRecalls & reported problems across all models
Navilyst Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 3 models of StarBurst Talon by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between May 17, 2017 and Oct 23, 2023 — classified as 2 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported StarBurst Talon problems
Device problems
- Detachment of Device or Device Component8
- Detachment Of Device Component3
- Fracture3
- Crack2
- Fluid/Blood Leak2
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Burn(s)1
StarBurst Talon models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- StarBurst Talon 700-102847ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES11 reports
- StarBurst Talon 700-102845ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES10 reports
- StarBurst Talon 700-102846ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent StarBurst Talon adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJun 5, 2019Obstruction of Flow; Obstruction of Flow
A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN RFA PROCEDURE. THE PATIENT WAS SEDATED AND THE PROCEDURE WAS INITIATED. THE TREATING PHYSICIAN ATTEMPTED TO USE THE TALON RF PROBE AND DURING THE TIME OF PURGING THE DEVICE, SALINE WOULD NOT DRIP FROM ALL 4 TINES, ONLY 2 HAD A SALINE DRIP. THE DEVICE HAD NOT BEEN PLACED WHEN THE DEFECT WAS NOTED. THE PHYSICIAN DETERMINED NOT TO CONTINUE WITH THE PROCEDURE. AS THE TREATMENT WAS NOT PROVIDED, AND THE PATIENT HAD BEEN SEDATED, THIS EVENT MEETS THE CRITERIA OF AN ADVERSE EVENT DUE TO PATIENT SAFETY RISK OF UNNECESSARY SEDATION. IT WAS REPORTED THE PATIENT SUFFERED NO HARM OR INJURY 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 8670486 ↗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 ↗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 ↗
Other Navilyst Medical, Inc. products
All Navilyst Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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