SoleroRecalls & reported problems across all models
Angiodynamics, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 154
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 4 models of Solero by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 154 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2017 and Apr 17, 2026 — classified as 25 injuries, 129 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (111 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 Solero problems
Device problems
- Detachment of Device or Device Component111
- Fracture21
- Temperature Problem19
- Adverse Event Without Identified Device or Use Problem9
- Output Problem3
- Activation, Positioning or Separation Problem2
- Crack2
- Detachment Of Device Component2
Patient problems
- Device Embedded In Tissue or Plaque101
- No Clinical Signs, Symptoms or Conditions23
- Foreign Body In Patient20
- No Consequences Or Impact To Patient12
- No Patient Involvement2
- Pneumothorax2
- Tachycardia2
- Burn(s)1
Solero models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Solero 700106001-USSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES92 reports
- Solero 700106002-USSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES46 reports
- Solero 700106003-USSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES9 reports
- Solero 12740000USSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES7 reports
Recent Solero adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE TREATING PHYSICIAN PLANNED TO PERCUTANEOUSLY TREAT FOUR LIVER LESIONS DURING THE ABLATION PROCEDURE. THE APPLICATOR WAS SUCCESSFULLY TESTED FOR 10 SECONDS AT 100 WATTS. THE UNIT WAS SET FOR 140 WATTS FOR 4 MINUTES TO TREAT THE FIRST LESION, THE SECOND LESION ABLATION WAS SET FOR 140 WATTS FOR 2 MINUTES, AND THE THIRD LESION ABLATION WAS SET FOR 100 WATTS FOR 2 MINUTES. ONE MINUTE INTO THE ABLATION FOR THE THIRD LESION, THE UNIT DISPLAYED AN ERROR 209 "COOLANT TEMPERATURE >52". THE UNIT WAS TURNED OFF AND RESTARTED AFTER 2 MINUTES AND THE PROCEDURE WAS PROCEEDED TO TREAT THE FOURTH LESION. THE APPLICATOR HAD BEEN REMOVED AND INSPECTED BETWEEN EACH ABLATION CYCLE. THE FOURTH LESION TREATMENT WAS PERFORMED AT 140 WATTS FOR 1 MINUTE. WHEN THE RADIOLOGIST REMOVED THE APPLICATOR, IT WAS NOTED THE CERAMIC TIP OF THE APPLICATOR HAD BROKEN OFF INSIDE THE PATIENT. THE RADIOLOGIST WAS CONFIDENT THE TIP WOULD NOT MOVE OR MIGRATE, SO IT WAS DETERMINED TO NOT ATTEMPT TO REMOVE THE TIP. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24909535 ↗MalfunctionApr 16, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE APPLICATOR WAS TESTED FOR 10 SECONDS AT 120 WATTS PER PROTOCOL WITH NO ISSUES. THE APPLICATOR WAS PLACED FOR THE PERCUTANEOUS MICROWAVE PROCEDURE OF THE LIVER, WITH THE UNIT SET FOR 5 MINUTES, 120WATTS. A "HIGH REFLECTED POWER, REPOSITION PROBE AND TRY AGAIN" WAS RECEIVED APPROXIMATELY 15 SECONDS AFTER THE ABLATION STARTED. THE APPLICATOR WAS WITHDRAWN TO REPOSITION IT AT WHICH TIME IT WAS NOTED THE TIP HAD DETACHED INSIDE OF THE PATIENT'S LIVER. ANOTHER APPLICATOR WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24904983 ↗MalfunctionApr 9, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED FOR 1 MINUTE AT 140 WATTS. THE UNIT WAS SET FOR 6 MINUTES AT 100 WATTS AND THE APPLICATOR WAS PERCUTANEOUSLY PLACED IN THE PATIENT'S LIVER. AFTER ONE MINUTE OF ABLATING, A HIGH REFLECTED POWER MESSAGE DISPLAYED. THE APPLICATOR WAS REPOSITIONED WITHOUT WITHDRAWING FOR INSPECTION, AND A NEW IMAGE WAS TAKEN. THE IMAGE SHOWED THE TIP HAD DETACHED INSIDE OF THE PATIENT. THEY IMMEDIATELY EXCHANGED THE APPLICATOR WITH A 19CM APPLICATOR AND PERFORMED THREE CYCLES: 1ST OF 6 MINUTES AT 100W POWER, 2ND OF 4 MINUTES AT 100W POWER, AND 3RD OF 4 MINUTES AT 100W POWER TO FINALIZE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 24831685 ↗MalfunctionMar 4, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR WAS TESTED PRIOR TO THE PROCEDURE WITH NO ISSUES. AT THE START OF THE PERCUTANEOUS MICROWAVE ABLATION OF THE LIVER, A "HIGH REFLECTED POWER" MESSAGE WAS IMMEDIATELY RECEIVE. NO ABLATIONS HAD BEEN PERFORMED.THE APPLICATOR WAS REPOSITIONED SEVERAL TIMES, HOWEVER THE MESSAGE WAS STILL RECEIVED. THE APPLICATOR WAS REMOVED AT WHICH TIME IT WAS OBSERVED THE TIP HAD DETACHED AND REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24505716 ↗MalfunctionMar 4, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. PRIOR TO PERCUTANEOUS INSERTION, THE APPLICATOR WAS TESTED FOR 10 SECONDS WITH NO REPORTED ISSUES. THE FIRST ABLATION OF THE PATIENT'S LIVER WAS PERFORMED AT 60 W FOR 4 MINUTES, WITHOUT COMPLICATIONS. THE APPLICATOR WAS REMOVED AND INSPECTED PRIOR TO REINSERTION FOR THE SECOND ABLATION. FOR THE SECOND ABLATION, THE UNIT WAS SET FOR 4 MINUTES AT 100 W. AFTER ONE MINUTE OF ABLATING. THE UNIT REPORTED AN ERROR 209. IT WAS CONFIRMED THE SALINE WAS COOLED; HOWEVER, THEY DECIDED TO REPLACE THE SALINE. WHEN THE ABLATION WAS RESTARTED THE UNIT DISPLAYED A "HIGH REFLECTED POWER (HRP)" MESSAGE. THE APPLICATOR WAS REPOSITIONED BUT NOT REMOVED. THE HRP CONTINUED TO DISPLAY, SO THE UNIT WAS UNPLUGGED FOR TWO MINUTES, AND THE PROCEDURE WAS STARTED AGAIN. THE HRP CONTINUED TO DISPLAY, THEREFORE, THE APPLICATOR WAS WITHDRAWN, AT WHICH POINT IT WAS OBSERVED THAT THE CERAMIC TIP HAD DETACHED AND REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS NOT CONTINUED DUE TO THIS EVENT. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24505715 ↗MalfunctionFeb 23, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19 CM SOLERO APPLICATOR. AFTER TESTING THE APPLICATOR, THE PHYSICIAN PLACED IT IN THE PATIENT, INTENDING TO ABLATE FOR 4 MINUTES AT 140 WATTS. WHEN THE PHYSICIAN APPLIED ENERGY, THE TIP "BLEW UP" AND THE PROBE STOPPED WORKING. AN UNKNOWN ERROR CODE HAD APPEARED ON THE UNIT. THE APPLICATOR WAS EXCHANGED FOR ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24418544 ↗MalfunctionFeb 12, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED FOR 30 SECONDS AT 100 WATTS PRIOR TO THE PROCEDURE. THE PHYSICIAN PLANNED TO PERCUTANEOUSLY TREAT THE PATIENT'S LIVER LESION FOR A MEASURED AREA OF 22X17X13MM AT 140 WATTS FOR 6 MINUTES. AFTER 4 MINUTES OF ABLATION, THE UNIT DISPLAYED A HIGH REFLECTED POWER MESSAGE. SHE TRIED TO REPOSITION THE APPLICATOR, HOWEVER SHE WAS UNABLE TO CLEAR THE MESSAGE AND CONTINUE THE PROCEDURE. UPON WITHDRAWING THE APPLICATOR, IT WAS OBSERVED THE TIP WAS NO LONGER ATTACHED AND WAS RETAINED NEAR THE LIVER CAPSULE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE TIP WAS SUBSEQUENTLY LATER REMOVED LAPROSCOPICALLY. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24321993 ↗MalfunctionFeb 12, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR WAS TESTED IN SALINE FOR 1 MINUTE AT 140 WATTS WITH NO ISSUES. THE DOCTOR PERCUTANEOUSLY POSITIONED THE APPLICATOR IN THE PATIENT'S KIDNEY. THE UNIT WAS SET FOR 4 MINUTES AT 140 WATTS. HALFWAY THROUGH THE ABLATION, A "HIGH REFLECTED POWER" MESSAGE DISPLAYED. THE DOCTOR WAS ADVISED TO REPOSITION THE APPLICATOR. BEFORE REPOSITIONING THE APPLICATOR, AN IMAGE WAS TAKEN, WHERE IT WAS OBSERVED THE CERAMIC TIP HAD DETACHED INSIDE OF THE PATIENT. A SECOND APPLICATOR WAS OPENED IN ORDER TO CONTINUE THE PROCEDURE. THEY PERFORMED TWO 2-MINUTE CYCLES AT 140 WATTS, COMPLETING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT. THE DOCTOR HAS BEEN USING SOLERO PRODUCT SINCE 2019.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24321992 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
A PMCF SURVEY REPORTED THAT A PATIENT DIAGNOSED WITH HEPATOCELLULAR CARCINOMA (HCC) EXPERIENCED HYPOTENSION DURING A SOLERO MICROWAVE THERMAL ABLATION PROCEDURE USING A 14CM SOLERO PROBE. THE 14CM SOLERO PROBE WAS PLACED PERCUTANEOUSLY IN THE PATIENT'S LIVER UNDER CT AND FLUOROSCOPY IMAGING. THE SIZE OF THE TARGET AREA WAS 3CM X 2.5CM X 2.5CM. THE PROBE WAS PLACED SUCCESSFULLY WITH THE DISTAL TIP VISUALIZED VIA IMAGING. THE SURGICAL TECHNIQUE OF HYDRODISSECTION WAS USED. ONE ABLATION WAS PERFORMED AND COMPLETED AT 100 WATTS FOR 4 MINUTES. DURING THAT TIME, THE PATIENT EXPERIENCED HYPOTENSION WHICH WAS ABLE TO BE RESOLVED AFTER PAUSING THE ABLATION AND GIVING THE PATIENT MEDICATION. THE PATIENT HAD NOT BEEN PREVIOUSLY TREATED WITH ANY OTHER DEVICES OR MEDICATION PRIOR TO THIS SOLERO PROCEDURE.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 24321991 ↗MalfunctionFeb 10, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE PHYSICIAN WAS PERFORMING A LAPAROSCOPIC MICROWAVE ABLATION OF THE LIVER ON A PATIENT. HE ABLATED AT 140W FOR 4 MINS FOR A SINGLE BURN, AND WHEN HE REMOVED THE PROBE, THE TIP WAS NOT THERE. THE TIP WAS RETAINED IN THE PATIENT'S LIVER. THE DOCTOR MADE THE DECISION TO NOT REMOVE THE TIP. THERE WERE NO ERROR MESSAGES FROM THE SOLERO GENERATOR DURING THE BURN, AND NO ADJUNCT TOOLS HAD BEEN USED. THE DOCTOR HAS BEEN PERFORMING MICROWAVE PROCEDURES FOR 10 YEARS.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24308126 ↗MalfunctionFeb 10, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE APPLICATOR WAS TESTED PRIOR TO PERCUTANEOUS INSERTION FOR 10SEC @ 60 WATTS. THE UNIT WAS SET FOR 3MIN. @ 100 WATTS FOR THE PROCEDURE. THE APPLICATOR WAS PLACED IN A SOLITARY LIVER LESION, SEGMENT VI, WHEN A HIGH REFLECTED POWER MESSAGE WAS RECEIVED. NO ABLATION HAD BEEN PERFORMED. THE MESSAGE WAS UNABLE TO BE CLEARED, THEREFORE THE APPLICATOR WAS REMOVED AND INSPECTED, WHEN IT WAS OBSERVED THE TIP HAD DETACHED AND WAS RETAINED INSIDE THE PATIENT'S LIVER. THE APPLICATOR WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24308125 ↗MalfunctionFeb 4, 2026Adverse Event Without Identified Device or Use Problem
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED AND THEN INSERTED INTO THE PATIENT'S LUNG. WHEN ATTEMPTING TO ABLATE, THEY RECEIVED A HIGH REFLECTED POWER MESSAGE. NO ABLATION HAD BEEN APPLIED AS OF YET. THE APPLICATOR WAS EXCHANGED FOR ANOTHER ONE AND THEY ALSO EXCHANGED THE SOLERO UNIT IN ORDER TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED A PNEUMOTHORAX DURING THIS EVENT.
Patient problems: Pneumothorax
MAUDE report 24261445 ↗MalfunctionJan 19, 2026Fracture; Detachment of Device or Device Component
AN END USER REPORTED THAT DURING A MICROWAVE ABLATION PROCEDURE USING A 14CM SOLERO PROBE UNDER CT GUIDANCE. THE TIP OF THE PROBE FRACTURED OFF AND WAS RETAINED INSIDE THE PATIENT'S LIVER. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED WITH THIS DEVICE, AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24108718 ↗MalfunctionJan 19, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED AT 100 WATTS FOR 10 SECONDS FOR A PERCUTANEOUS LIVER ABLATION. THE UNIT WAS SET FOR 140 WATTS FOR 2 MINUTES AND THREE ABLATIONS WERE PERFORMED WITH NO REPORTED ISSUES. THE TIP WAS INSPECTED UPON REMOVAL. FOR THE FOURTH AND FINAL ABLATION AT 140 WATTS FOR 2 MINUTES, A SECOND PROBE WAS USED. UPON STARTING THE FINAL ABLATION, THEY RECEIVED A "HIGH REFLECTIVE POWER" MESSAGE. THE DOCTOR PAUSED THE ABLATION AND PERFORMED A CT SCAN. HE IDENTIFIED FOUR PROBE ARTIFACTS SCATTERED THROUGHOUT THE LIVER. AT THAT POINT THE DOCTOR CONCLUDED THE CASE.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24108717 ↗MalfunctionDec 20, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR WAS TESTED FOR 10 SECONDS AT 100 WATTS PRIOR TO USE WITH NO ERRORS. THEY THEN PERFORMED AN PERCUTANEOUS (OPEN) MICROWAVE ABLATION AT 140 WATTS FOR 4 MINUTES WITH NO ERRORS OR ISSUES. AT THE CONCLUSION OF THE ABLATION, THEY TRACK ABLATED OUT OF THE LIVER FOR 30SECONDS AT 100WATTS. UPON REMOVING THE PROBE, IT WAS OBSERVED THAT 1.2CM OF THE PROBE TIP WAS MISSING AND RETAINED IN THE PATIENT'S LIVER. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN TIP BUT WAS UNSUCCESSFUL. XRAY WAS CALLED IN AND THEY WERE ABLE TO LOCATE BROKEN TIP, HOWEVER IT WAS DETERMINED TO LEAVE THE TIP IN THE LIVER. THE PATIENT WILL RECEIVE CT FOR FOLLOW UP.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 23858903 ↗
Other Angiodynamics, Inc. products
- Soft-Vu54 models · 66 reports · 18 recalls
- Mini Stick MAX12 models · 2 reports · 12 recalls
- Smart Port CT36 models · 479 reports
- VenaCure EVLT15 models · 437 reports
- AccuVu9 models · 14 reports · 4 recalls
- DuraMax8 models · 23 reports · 3 recalls
- DuraFlow6 models · 8 reports · 2 recalls
- NanoKnife9 models · 44 reports · 1 recall
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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