Soloist™ M001262500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729122487), received between Jun 15, 2021 and May 8, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (5 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026High impedance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A SOLOIST? NEEDLE WAS SELECTED FOR USE TO TREAT AN OSTEOID OSTEOMA. THE PATIENT WAS SEDATED USING GENERAL ANESTHESIA. AT THE START OF THE PROCEDURE, WHILE CONNECTING THE ELECTRODE, THERE WAS A HIGH IMPEDANCE ERROR. DESPITE TROUBLESHOOTING THE ERROR FOR BETWEEN 2-3 HOURS, THE ERROR WAS UNABLE TO BE RESOLVED. THERE WAS NO REPLACEMENT DEVICE AVAILABLE, SO THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128471 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AS A RESULT OF THE DEVICE OR PROCEDURE AND REQUIRED MEDICATION. SOLOIST RADIOFREQUENCY ABLATION (RFA) PROBES WERE SELECTED FOR USE TO TREAT A PEDIATRIC PATIENT WITH AN OSTEOID OSTEOMA. PRE-PROCEDURE CT (COMPUTED TOMOGRAPHY) (0.6 MM) AND CONTRAST MRI (MAGNETIC RESONANCE IMAGING) HAD CLEARLY DEMONSTRATED A CLASSICAL NIDUS. INTRA-PROCEDURAL CT IMAGES UNEQUIVOCALLY SHOW THAT THE RFA PROBE TIP WAS PLACED PRECISELY WITHIN THE NIDUS, WITH CORRECT TRAJECTORY AND DEPTH. ENERGY DELIVERY WAS PERFORMED STRICTLY AS PER MANUFACTURER-RECOMMENDED PARAMETERS. HOWEVER, RECENT FOLLOW-UP MRI DEMONSTRATES PERSISTENT, ENHANCING NIDUS WITH CONTINUED CLINICAL SYMPTOMS, CONCLUSIVELY ESTABLISHING THAT THE LESION HAD NOT BEEN ABLATED. THE PATIENT EXPERIENCED WORSENING AND PROLONGED PAIN AND DISCOMFORT AS A RESULT OF THE DEVICE OR PROCEDURE, AND REQUIRED MEDICATION TO BE ADMINISTERED. THE PATIENT WAS PRESCRIBED NAPROXEN FOR 5 DAYS FOLLOWING THE PROCEDURE.

  Patient problems: Discomfort; Pain

  MAUDE report 24308658 ↗
• MalfunctionOct 10, 2025Device Displays Incorrect Message; Human-Device Interface Problem; Therapeutic or Diagnostic Output Failure; Device Displays Incorrect Message; Human-Device Interface Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST SEDATION. A SOLOIST? SINGLE NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN AN OSTEOID OSTEOMA WITH BENIGN TUMOR. THE PATIENT WAS UNDER GENERAL ANESTHESIA. AFTER OBTAINING ACCESS AND DEPLOYING THE DEVICE, AN ATTEMPT WAS MADE TO START ABLATION, BUT THE GENERATOR SHOWED AN ERROR 2. TROUBLESHOOTING WAS ATTEMPTED, BUT THE ERROR 2 DISPLAYED CONTINUOUSLY, SO THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266147 ↗
• MalfunctionOct 28, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. A SOLOIST SINGLE NEEDLE ELECTRODE WAS SELECTED FOR USE IN AN OSTEOID OSTEOMA RADIOFREQUENCY ABLATION PROCEDURE. DURING THE PROCEDURE, THE IMPEDANCE WAS NOT RISING. AFTER MULTIPLE ATTEMPTS, THE TUMOR COULD NOT BE ABLATED, AND THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547027 ↗
• MalfunctionSep 20, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL-OFF OCCURRED AND THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE OSTEOID OSTEOMA IN THE RIGHT LEG TIBIA BONE. THE SOLOIST NEEDLE WAS ADVANCED THROUGH A 13 GAUGE 10CM BIOPSY NEEDLE. AFTER POSITIONING THE SOLOIST NEEDLE, THE BIOPSY NEEDLE WAS PULLED BACK 1.5 CM AND ABLATION WAS STARTED IN THE LESION. LESION SIZE WAS 7 MM. AFTER THE FIRST ABLATION CYCLE OF 15 MIN, NO IMPEDANCE WAS ACHIEVED. THE IMPEDANCE REMAINED CONSTANT AT 260 TO 270. THE 2ND CYCLE WAS STARTED FROM 70% OF THE HIGHEST SET POWER OF 1ST CYCLE, AND CONTINUED FOR 5 MIN AT THE SAME POWER THEN START INCREASING POWER AS 1WATT/MIN, BUT IMPEDANCE WAS NOT ACHIEVED. IMPEDANCE REMAINED CONSTANT AT 260 TO 270. THE SAME PROCESS WAS REPEATED 5 TIMES AND IMPEDANCE WAS NOT ACHIEVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENTS STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459331 ↗
• MalfunctionSep 7, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING WAS COMING OFF THE TIP. A SOLOIST NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE OF AN OSTEOID OSTEOMA IN THE FEMORAL BONE. WHILE UNPACKING THE DEVICE, IT WAS OBSERVED THAT THE SOLOIST HAD A DEFECT IN INSULATION, AND THE PLASTIC COATING WAS COMING OUT FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375304 ↗
• MalfunctionJul 12, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. A SOLOIST SINGLE NEEDLE ELECTRODE WAS SELECTED FOR THE RADIOFREQUENCY ABLATION OF AN OSTEOID OSTEOMA. A 13 GAUGE X 10CM BONE BIOPSY NEEDLE WAS PLACED ON THE NIDUS AND THE SOLOIST NEEDLE WAS PASSED THROUGH IT. ABLATION WAS STARTED AND RAN FOR 15 MINUTES. AFTER 15 MINUTES, IMPEDANCE WAS NOT ACHIEVED AND ABLATION WAS RESTARTED. IMPEDANCE WAS UNABLE TO BE ACHIEVED DURING THE SECOND ATTEMPT. THE SOLOIST NEEDLE WAS REPOSITIONED BUT IMPEDANCE COULD NOT BE ACHIEVED. THE NEEDLE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991436 ↗
• MalfunctionApr 15, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED AND THE PROCEDURE WAS ABORTED. A SOLOIST SINGLE NEEDLE ELECTRODE WAS SELECTED FOR A RADIOFREQUENCY ABLATION (RFA) TREATMENT OF AN OSTEOID OSTEOMA IN THE LEFT FEMORAL HEAD. THE LESION HAD A 6.0MM DIAMETER NIDUS. THE PHYSICIAN USED A 11GAUGE X 10CM BONE BIOPSY NEEDLE TO GAIN ACCESS TO THE CENTER OF THE NIDUS. AFTER ACCESS TO THE CENTER OF THE NIDUS WAS OBTAINED, THE SOLOIST NEEDLE WAS PLACED THROUGH THE BIOPSY NEEDLE. THE BIOPSY NEEDLE WAS PULLED BACK ABOUT 2CM TO PREVENT ANY INTERFERENCE WITH THE ACTIVE PART OF THE SOLOIST NEEDLE. FOUR GROUNDING PADS WERE PLACED ON THE THIGHS OF THE PATIENT. ABLATION WAS STARTED PER THE PRESCRIBED ALGORITHM. IT WAS NOTED THAT THE FIRST ROLL OFF DIDN'T OCCUR WITHIN THE FIRST 15 MINUTES OF THE PROCEDURE. THE MACHINE WAS STOPPED AFTER THE FIRST 15 MINUTES COMPLETED. THERE WAS NO CHANGE IN IMPEDANCE ON THE METER. AFTER 60 SECONDS, THE SECOND ROUND OF ABLATION WAS STARTED. THERE WAS NO CHANGE IN IMPEDANCE FOR ANY WATTAGE BEING CHANGED. AFTER 30 MINUTES INTO THE SECOND ROUND OF ABLATION, THE PHYSICIAN REQUESTED TO STOP THE PROCEDURE AS THERE WAS NO CHANGE IN THE IMPEDANCE BEING SHOWN ON THE MONITOR. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117587 ↗
• MalfunctionNov 2, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE ERROR CODE E02 WAS RECEIVED DURING THE PROCEDURE AND WAS UNABLE TO BE RESOLVED. A SOLOIST SINGLE NEEDLE ELECTRODE WAS SELECTED FOR RADIO FREQUENCY (RF) ABLATION OF A TUMOR IN THE RADIUS BONE. THE ERROR CODE E02 WAS RECEIVED WHEN THE PHYSICIAN INSERTED THE ELECTRODE INTO THE PATIENT AND STARTED TREATMENT. THE ERROR MESSAGE WAS UNRESOLVED THROUGH TROUBLESHOOTING. THE PROCEDURE WAS RESCHEDULED FOR THE FOLLOWING DAY WHEN ANOTHER ELECTRODE AND RF GENERATOR WOULD BE AVAILABLE. THE PATIENT WAS SEDATED WHEN THE PROCEDURE HAD TO BE RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739703 ↗
• MalfunctionAug 3, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN E02 ERROR OCCURRED. A SOLOIST SINGLE NEEDLE ELECTRODE WAS SELECTED FOR USE DURING A OSTEOID OSTEOMA RADIOFREQUENCY ABLATION PROCEDURE. PATIENT WAS SEDATED AND READY WITH THE PADS CONNECTED TO THE RADIOFREQUENCY GENERATOR, AND WHEN THE ELECTRODE WAS CONNECTED IT REPEATEDLY GAVE AN E02 ERROR. THE PROCEDURE WAS EVENTUALLY ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271961 ↗
• MalfunctionJun 15, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST-SEDATION. A RF3000 RADIOFREQUENCY GENERATOR AND TWO SOLOIST SINGLE NEEDLE ELECTRODES WERE SELECTED FOR USE IN RADIOFREQUENCY TREATMENT OF AN OSTEOID OSTEOMA, A BENIGN BONE TUMOR THAT CAUSES PAIN. THE PATIENT WAS SEDATED. EVERYTHING WENT WELL ACCORDING TO THE PROTOCOL UNTIL THE START OF ABLATION. THE DEVICE GAVE AN E02 ERROR MESSAGE WHEN THE START BUTTON WAS PUSHED, AND IMPEDANCE RANGED FROM 400 TO 500 OHMS. ATTEMPTS WERE MADE TO START AND STOP THE DEVICE, FLUSH SALINE INTO THE BONE CANAL AND ABLATION TIP, DILATE CANAL, CHANGE NEEDLE POSITION AND ORIENTATION, CHECK PLACEMENT OF THE EARTHING HOSES, AND REPLACE NEW STRANDS (E.G., NEEDLE); HOWEVER, THE DEVICE CONTINUED TO GIVE THE E02 CODE AND WOULD NOT WORK. THE PATIENT COULD NOT BE TREATED, AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006041 ↗
• MalfunctionJun 15, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST-SEDATION. A RF3000 RADIOFREQUENCY GENERATOR AND TWO SOLOIST SINGLE NEEDLE ELECTRODES WERE SELECTED FOR USE IN RADIOFREQUENCY TREATMENT OF AN OSTEOID OSTEOMA, A BENIGN BONE TUMOR THAT CAUSES PAIN. THE PATIENT WAS SEDATED. EVERYTHING WENT WELL ACCORDING TO THE PROTOCOL UNTIL THE START OF ABLATION. THE DEVICE GAVE AN E02 ERROR MESSAGE WHEN THE START BUTTON WAS PUSHED, AND IMPEDANCE RANGED FROM 400 TO 500 OHMS. ATTEMPTS WERE MADE TO START AND STOP THE DEVICE, FLUSH SALINE INTO THE BONE CANAL AND ABLATION TIP, DILATE CANAL, CHANGE NEEDLE POSITION AND ORIENTATION, CHECK PLACEMENT OF THE EARTHING HOSES, AND REPLACE NEW STRANDS (E.G., NEEDLE); HOWEVER, THE DEVICE CONTINUED TO GIVE THE E02 CODE AND WOULD NOT WORK. THE PATIENT COULD NOT BE TREATED, AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006033 ↗