Solero 700106001-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI H787700106001US0), received between Jul 6, 2017 and Apr 17, 2026 — classified as 13 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (71 reports).

9 other recalls cover devices cleared under the same FDA submission (K162449); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, 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 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 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 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 ↗
• MalfunctionDec 20, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. PRIOR TO PLACEMENT, THE APPLICATOR WAS SUCCESSFULLY TESTED AT 140 WATTS FOR 10 SECONDS. THE UNIT WAS SET FOR 140 WATTS FOR 2 MINUTES AND THE APPLICATOR WAS PERCUTANEOUSLY PLACED. THE PROCEDURE WAS COMPLETED AND UPON REMOVAL OF THE APPLICATOR, THE PHYSICIAN NOTED THE TIP HAD FRACTURED OFF AND WAS RETAINED IN THE PATIENT'S KIDNEY. NO ERROR CODES HAD DISPLAYED DURING THE PROCEDURE. A UROLOGIST WAS CONSULTED, AND THEY DETERMINED SINCE THE PATIENT WAS FIT AND WELL, THEY WOULD DISCHARGE HIM AND REMOVE THE TIP IN A LATER SURGICAL PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 23858902 ↗
• MalfunctionDec 3, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. APPLICATOR WAS TESTED AS PER THE IFU. PROBE WAS PERCUTANEOUSLY PLACED INTO LIVER LESION, AND A 140W, 6MIN BURN WAS PERFORMED. UPON REMOVAL OF THE DEVICE, IT WAS NOTICED THAT THE TIP WAS MISSING AND CONFIRMED ON IMAGING. NO ERROR MESSAGES HAD POPPED UP ON THE GENERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23708321 ↗
• MalfunctionNov 10, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE RADIOLOGIST POSITIONED THE PROBE IN THE RIGHT LUNG AND THEY SET THE GENERATOR TO 140 WATTS FOR 4 MINUTES. AFTER 32 SECONDS THE GENERATOR SWITCHED OFF AND THE DISPLAY SHOWED " HIGH REFLECTIVE POWER". THEY RESET THE GENERATOR TO 100 WATTS FOR 6 MINUTES AND STARTED AGAIN. THE GENERATOR RAN FOR 4 MORE SECONDS AND THEN SWITCHED OFF AGAIN WITH "HIGH REFLECTIVE POWER " DISPLAYED. THE RADIOLOGIST PROCEEDED TO PERFORM A CT GUIDED SCAN AND DETERMINED THE CERAMIC TIP HAD FRAGMENTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23509724 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. AFTER UNPACKING A NEW APPLICATOR FOR A PERCUTANEOUS LIVER TUMOR ABLATION, A FUNCTIONAL TEST WAS PERFORMED AT 100W FOR 30 SECONDS, DURING WHICH THE PROBE FUNCTIONED NORMALLY. DURING THE FIRST ABLATION OF THE TARGET TUMOR, THE SETTINGS WERE 100 W FOR 2 MINUTES. AFTER APPROXIMATELY 2 SECONDS OF ABLATION, A "HIGH REFLECTED POWER" ERROR WAS DISPLAYED. THE PHYSICIAN IMMEDIATELY REMOVED THE PROBE, AND ONLY THE STAINLESS-STEEL PORTION OF THE PROBE TIP WAS PRESENT, THE CERAMIC TIP WAS MISSING. A SUBSEQUENT CT SCAN CONFIRMED THAT THE BROKEN CERAMIC TIP HAD REMAINED INSIDE THE PATIENT. A NEW ABLATION PROBE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WILL BE OBSERVED AND MONITORED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23486032 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. IT WAS REPORTED THE APPLICATOR HAD BEEN SUCCESSFULLY TESTED FOR 10 MINUTE AT 140 WATTS PRIOR TO PERCUTANEOUS INSERTION. TWO 4 MINUTE/100-WATT CYCLES WERE PERFORMED FOR THE ABLATION OF ONE LIVER NODULE IN SECTION 8. SATISFIED WITH THE TWO ABLATIONS CYCLES, THE DOCTOR STARTED TO DO TRACK ABLATION TO REMOVE THE APPLICATOR. WHEN THE APPLICATOR WAS WITHDRAWN IT WAS NOTED THE TIP WAS MISSING AND HAD BEEN RETAINED INSIDE THE PATIENT. THE PATIENT WAS REPORTED AS STABLE AND WILL BE OBSERVED. ADDITIONAL INFORMATION: NO ERROR CODES DISPLAYED DURING THE ABLATIONS. THE APPLICATOR WAS NOT INSPECTED BETWEEN ABLATIONS. THE PHYSICIAN HAS EXPERIENCE AND HAS BEEN USING SOLERO SINCE 2021.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23485906 ↗
• MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED THAT AN END USER EXPERIENCED ISSUES WITH TWO 14CM SOLERO PROBES DURING A PATIENT'S PERCUTANEOUS LIVER ABLATION PROCEDURE. THE FIRST PROBE WAS TESTED SUCCESSFULLY AT 100W FOR 1 MINUTE; THEREFORE, THE GENERATOR WAS THEN SET AT 140W FOR 6 MINUTES AND THE PROCEDURE WAS STARTED. THE GENERATOR GAVE A "HIGH REFLECTIVE POWER" ERROR MESSAGE, AFTER ONLY 2-3 SECONDS, AND UPON REMOVING THE APPLICATOR FROM THE PATIENT, THE TIP APPEARED TO BE DISCOLORED BUT NOT MELTED OR CHARRED. DURING USE OF THE SECOND PROBE, A "HIGH REFLECTIVE POWER" ERROR MESSAGE OCCURRED, AND THE TIP OF THE APPLICATOR IS RETAINED WITHIN THE PATIENT. THE UNIT SETTING WERE 100W FOR 1 MIN. AND THE PROBE HAD BEEN SUCCESSFULLY TESTED PRIOR TO INSERTION. THE MESSAGE CAME AFTER 2 TO 3 SECONDS OF BEGINNING TO ABLATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22942898 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS CLINICAL SPECIALIST (CS) REPORTED THAT THE TIP OF A 14CM SOLERO MICROWAVE ABLATION APPLICATOR, DETACHED DURING A PROCEDURE, FOR WHICH THEY WERE PROVIDING IN PERSON COVERAGE. THE FOLLOWING NARRATIVE WAS PROVIDED BY THE CS: THE APPLICATOR WAS TESTED FOR 10 SECONDS AT 100WATTS. THE APPLICATOR WAS PERCUTANEOUSLY PLACED WITH NO REPORTED DIFFICULTY. THE FIRST ABLATION SITE WAS ON THE LATERAL-MOST EDGE OF THE LIVER AND WAS COMPLETED USING 100W FOR A TOTAL OF 1:40S SUCCESSFULLY AND WITHOUT INCIDENT. TRACK ABLATION WAS COMPLETED; PROBE WAS INSPECTED AND CLEANED OF ANY CHAR OR TISSUE RESIDUE BEFORE REINSERTION. SECOND ABLATION SITE WAS IN VERY CLOSE PROXIMITY TO THE GALLBLADDER AND APPROXIMATELY 1.5-2CM FROM A METAL BILIARY STENT. CAUTION WAS STRONGLY ENCOURAGED IN REGARD TO MAINTAINING APPROPRIATE DISTANCE FROM BOTH STRUCTURES. PROBE WAS SUCCESSFULLY PLACED INTO LESION WITH APPROPRIATE DISTANCE FROM CRITICAL STRUCTURES. FOR ADDITIONAL CLEARANCE FROM THE GALLBLADDER, THE DOCTOR DECOMPRESSED THE GALLBLADDER BY ASPIRATING BILE BY USING ULTRASOUND ACCESS WITH CHIBA NEEDLE. HE THEN INJECTED IODINATED CONTRAST INTO THE AREA FOR INCREASED VISUALIZATION. CAUTION WAS ENCOURAGED, AS

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22701001 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOLERO APPLICATOR. A PATIENT PRESENTED FOR A PERCUTANEOUS MICROWAVE ABLATION OF THE LIVER USING ULTRASOUND GUIDANCE. THE APPLICATOR WAS TESTED PRIOR TO INSERTION WITH NO REPORTED ISSUES. THE FIRST PASS TO THE LESION WAS PERFORMED WITH NO LATERAL FORCES APPLIED. THEY PERFORMED A 100WATT 6-MINUTE BURN SUCCESSFULLY. DURING THE SECOND ABLATION AT 140 WATTS, 4 MINUTES, A HIGH REFLECTIVE POWER MESSAGE WAS RECEIVED. A TRACT ABLATION WAS PERFORMED AND UPON REMOVAL OF THE APPLICATOR IT WAS NOTED THE TIP HAD DETACHED. THERE ARE NO PLANS TO REMOVE THE TIP FROM THE PATIENT. THE DOCTOR HAS BEEN USING SOLERO SINCE 2017. THE DOCTOR WAS TRAINED BY HIS FELLOW COLLEAGUES ON THE DEVICE AS WELL AS A GETZ HEALTHCARE REPRESENTATIVE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22461867 ↗
• MalfunctionJul 9, 2025Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING TWO SOLERO APPLICATORS AND A SOLERO UNIT. THE FIRST APPLICATOR WAS SUCCESSFULLY TESTED IN SALINE. THE APPLICATOR WAS PLACED IN THE PATIENT AND THE ABLATION WAS STARTED AT 120WATTS. THE UNIT CUTOUT AFTER 1 MINUTE DUE TO A HIGH REFLECTIVE POWER ALERT. THE APPLICATOR WAS REMOVED AT WHICH TIME IT WAS NOTED THE TIP OF THE APPLICATOR WAS BLACK/CHARRED. THE SECOND APPLICATOR WAS TESTED AND PLACED, AND AGAIN THE UNIT SHOWED A HIGH REFLECTIVE POWER. THEY DECIDED TO SWAP THE GENERATOR FOR A BACK UP UNIT AND THE PROCEDURE WAS COMPLETED WITH THE SECOND APPLICATOR AND UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461863 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. A PATIENT WITH RCC PRESENTED FOR A PERCUTANEOUS MICROWAVE ABLATION OF THE KIDNEY. THE APPLICATOR WAS SET UP AND TESTED AT 100WATTS FOR 20 SECONDS. THE UNIT WAS SET FOR 100W @ 3 MINUTES AND THE PATIENT WAS PLACED IN A PRONE POSITION FOR ACCESS. THE ABLATION WAS PERFORMED WITHOUT ISSUE, HOWEVER, WHEN THE POST CT SCAN WAS PERFORMED, IT WAS OBSERVED THE TIP HAD DETACHED INSIDE THE PATIENT'S KIDNEY. THE APPLICATOR WAS THEN CHECKED, AND IT WAS CONFIRMED THE TIP HAD DETACHED. NO ERROR MESSAGES HAD DISPLAYED DURING THE PROCEDURE. THE DOCTOR SAID HE DOES NOT BELIEVE IN ITS POSITION THAT IT WILL COMPROMISE THE PATIENT'S HEALTH MOVING FORWARD. ADDITIONAL INFORMATION: NO ADJUNCT TOOLS WERE USED. DOCTOR HAS BEEN USING SOLERO AND PERFORMING MWA CASES FOR 12 YEARS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22371675 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CLINICAL AFFAIRS DIRECTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOLERO APPLICATOR. A PATIENT PRESENTED FOR A MICROWAVE ABLATION OF THE LIVER.THE APPLICATOR WAS SUCCESSFULLY TESTED AT 100 WATTS FOR 20 SECONDS. IT WAS PERCUTANEOUSLY PLACED WITH NO NOTED DIFFICULTY. AT 3:41 MINUTES AT 140 WATTS, AN HEAT ERROR MESSAGE APPEARED ON THE UNIT WITH 20 SECONDS REMAINING. IT WAS REPORTED THAT APPROXIMATELY 1.5CM OF THE TIP HAD DETACHED AND WAS RETAINED IN THE PATIENT'S LIVER. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22371578 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CLINICAL SPECIALIST REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. A PATIENT PRESENTED FOR A PERCUTANEOUS MICROWAVE ABLATION OF THE LIVER. THE APPLICATOR WAS TESTED AT 100W FOR 10 SECONDS. THE SETTINGS FOR THE PROCEDURE WERE 140W FOR 4MINUTES. DURING THE PROCEDURE, AFTER 4 SECONDS, THE ABLATION CUT OFF WITH A HIGH REFLECTIVE POWER ERROR MESSAGE. THE PROBE WAS REMOVED WITHOUT ANY DIFFICULTY, BUT UPON REMOVAL THE RADIOLOGIST OBSERVED THE TIP HAD DETACHED. DUE TO THIS EVENT, THE PROCEDURE WAS ABORTED. A SUBSEQUENT CT SCAN SHOWED THE TIP WAS LODGED IN THE TARGET LESION. THERE ARE NO PLANS TO REMOVE THE TIP, AS IT WOULD REQUIRE OPEN SURGERY. THE DOCTOR'S TRAINING IS 8-10 YEARS, TRAINING WAS PROVIDED BY ANGIODYNAMICS. THE TOTAL TIME OF THE ABLATION WAS 4 SECONDS. NO ADJUNCT TOOLS WERE USED DURING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22308173 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN AGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A 14CM SOLERO APPLICATOR. PRIOR TO PERCUTANEOUSLY INSERTING THE APPLICATOR INTO THE KIDNEY, THE APPLICATOR WAS TESTED FOR 100 WATTS FOR 10 SECONDS IN CHILLED STERILE WATER. UPON TESTING AT THOSE SETTINGS, THE PROBE READ AT 134 WATTS. THE TEST WAS ABORTED AND RESTARTED. THE SECOND TEST READING WAS 94 WATTS WHICH WAS ACCEPTABLE. THE UNIT WAS SET FOR 100 WATTS FOR 5 MINUTES. THE ABLATION WAS STARTED AND ONLY 1 ABLATION CYCLE WAS PERFORMED. NO ERROR CODES WERE RECEIVED DURING THE ABLATING. THERE WAS NO DIFFICULTY IN REMOVING THE APPLICATOR AND NO ADJUNCT TOOLS HAD BEEN USED DURING THE PROCEDURE. FOLLOWING THE MICROWAVE ABLATION PROCEDURE, IMAGING LOCATED THE TIP OF THE APPLICATOR WITHIN THE KIDNEY. THE DECISION WAS MADE TO LEAVE THE TIP IN SITU AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE IT. THIS WAS THE DOCTOR'S FIRST TIME USING THE SOLERO IN THE KIDNEY, AND HIS FIRST TIME USING SOLERO. THE PHYSICIAN WAS TRAINED BY THE REPRESENTATIVE BUT HAS BEEN USING MICROWAVE FOR 5 YEARS. TOTAL TIME FOR THE ABLATION WAS 5 MINUTES. ABLATION SIZE WAS 3CMX3CM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22292760 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH A 14CM SOLERO APPLICATOR. ONE MINUTE AFTER STARTING A LIVER MICROWAVE ABLATION PROCEDURE, A HIGH TEMPERATURE ERROR OCCURRED. WHEN REMOVING THE NEEDLE FROM THE PATIENT, THE NEEDLE WAS FOUND TO BE BURNT AND MISSING THE TIP. THE TIP REMAINS IN THE PATIENT AND THE LIVER TUMOR ABLATION PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. THE DOCTOR IS WAITING FOR A CERTAIN AMOUNT OF TIME TO PROCEED WITH THE ABLATION PROCEDURE AGAIN AND DETERMINE HOW TO REMOVE THE TIP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22292536 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162449. One submission often covers many models, so check the product and lot details in each record.

• Z-2438-2021 · Jul 20, 2021 · Terminated
  Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
• Z-2437-2021 · Jul 20, 2021 · Terminated
  Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
• Z-2436-2021 · Jul 20, 2021 · Terminated
  Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
• Z-2439-2021 · Jul 20, 2021 · Terminated
  Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
• Z-1703-2019 · Apr 17, 2019 · Terminated
  AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog
• Z-1701-2019 · Apr 17, 2019 · Terminated
  AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished U
• Z-1700-2019 · Apr 17, 2019 · Terminated
  AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 1274000
• Z-1702-2019 · Apr 17, 2019 · Terminated
  AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog
• Z-1704-2019 · Apr 17, 2019 · Terminated
  AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Nu