StarBurst Talon 700-102846Recalls & reported problems
Navilyst Medical, Inc. · RITA StarBurst Talon Electrosurgical Device · Class 2
All models of StarBurst Talon (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H7877001028461), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
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
Device problems
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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 · TerminatedStarburst 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 · TerminatedXLie 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 · TerminatedTalon 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-
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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