Solero 700106002-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI H787700106002US0), received between Aug 31, 2017 and Apr 16, 2026 — classified as 11 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (31 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 46 reports, in the reporter's own words as published by the FDA.

• 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 THE APPLICATOR WAS WITHDRAWN TO REPOSITION IT AT WHICH TIME IT WAS NOTED THE TIP HAD DETACHED INSIDE OF THE PATIENT'S LIVER.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 ↗
• 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 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 ↗
• MalfunctionDec 19, 2025Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED IN SALINE FOR 10 SECONDS @ 100 WATTS. IT WAS PLACED IN THE PATIENT'S LUNG AND THE UNIT WAS SET FOR 3 MINUTES @ 120 WATTS WHEN THE UNIT DISPLAYED A HIGH REFLECTED POWER MESSAGE. THE PATIENT WAS SCANNED, SHOWING THE NEEDLE WAS INTACT. LEAVING THE PROBE IN PLACE, A SECOND SOLERO GENERATOR WAS BROUGHT IN AND THE PROBE WAS CONNECTED. THE PROCEDURE WAS PERFORMED FOR 3 MINUTES @ 120 WATTS. WHEN THE PROBE WAS REMOVED THERE WAS NOTED CHARRING ON THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848287 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED AT 100WATTS FOR 10 SECONDS. THE UNIT WAS SET AT 140 WATTS FOR 6 MINUTES WHICH WAS PURCUTAEOUSLY PERFORMED WITH NO ISSUES. THE UNIT WAS THEN SET FOR 140 WATTS FOR 4 MINUTES. DURING THAT ABLATION CYCLE, A TEMPERATURE ERROR DISPLAYED. THE APPLICATOR WAS WITHDRAWN AND IT WAS OBSERVED THE TIP OF THE APPLICATOR HAD DETACHED INSIDE OF THE PATIENT'S LIVER. THE TIP WAS LEFT IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT AND FAMILY WERE MADE AWARE OF THE SITUATION. IT WAS REPORTED THE PATIENT IS STABLE AND DOING WELL POST SURGERY. ADDITIONAL INFORMATION: THE PHYSICIAN HAS BEEN USING SOLERO PRODUCT FOR OVER FIVE YEARS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23708323 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATED EVENT DESCRIPTION: A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOLERO 19CM APPLICATOR. THE APPLICATOR WAS TESTED PRIOR TO INSERTION WITH NO ISSUES. THE DOCTOR PLANNED A PERCUTANEOUS THERMAL ABLATION OF THE LIVER LESION, 12X17MM, SECTION SVII, UNDER CT-GUIDANCE USING ONE ABLATION CYCLE OF 4 MINUTES AT 140 WATT. UNDER STERILE CONDITIONS AND LOCAL ANESTHESIA WITH SCANDICAIN 1%, THE ABLATION PROBE WAS PLACED UNDER CT GUIDANCE WITH THE PATIENT AWAKE. THE CORRECT POSITION WAS VERIFIED USING A CT SPIRAL. THE SHORT-ACTING ANESTHETIC WAS THEN ADMINISTERED. AFTER 3 MINUTES AND 20 SECONDS, A HIGH REFLECTIVE POWER MESSAGE APPEARED. THE ERROR COULD NOT BE RESOLVED, AND SINCE HE HAD PLANNED A LARGER ABLATION AREA ANYWAY (40 X 50 MM), HE REMOVED THE NEEDLE. A TRACT ABLATION WAS NOT POSSIBLE. UPON WITHDRAWAL OF THE APPLICATOR, IT WAS NOTED THAT 14 MM OF THE CERAMIC TIP WAS MISSING AND REMAINED IN THE PATIENT. THE EXTRACORPOREAL END OF THE PROBE APPEARED DARK AND CHARRED. THE FOLLOW-UP SCAN SHOWED THE PROBE TIP REMAINING INTRAPARENCHYMALLY IN THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS INFORMED OF THE ISSUE AND MAY REQUIRE A

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23004779 ↗
• MalfunctionAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19 CM SOLERO APPLICATOR. IT WAS REPORTED THE TIP OF THE SOLERO PROBE DETACHED AND REMAINS IN THE PATIENT'S LIVER. THEY HAD BEEN USING IT FOR 6 MINUTES AT 100W, INCREASED IT TO 120W, AND SUDDENLY IT REPORTED OVERHEATING. THE LESION WAS FILLED WITH LIPIODOL, SO POSSIBLY HIGHER TEMPERATURES THAN NORMAL. THEY STOPPED FURTHER TREATMENT, PULLED OUT THE NEEDLE AND IT CAME WITHOUT THE TIP. THE PROCEDURE HAD BEEN COMPLETED WITH THIS DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22829191 ↗
• 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 19CM SOLERO APPLICATOR. A PATIENT PRESENTED FOR A PERCUTANEOUS MICROWAVE ABLATION PROCEDURE OF THE LIVER. THE APPLICATOR WAS SUCCESSFULLY TESTED PRIOR TO INSERTION FOR 10 SECONDS AT 60 WATTS. DURING THE MICROWAVE PROCEDURE, THE APPLICATOR REQUIRED MULTIPLE POSITIONINGS. AFTER THE SECOND REPOSITIONING, IT WAS OBSERVED THE APPLICATOR WAS SLOWLY LEAKING SALINE AT THE TIP. THE SURGEON CONTINUED THE PROCEDURE AS THE SALINE WAS STERILE. DURING THE THIRD CYCLE, AT 2 MINUTES AND 30 SECONDS OF A 6-MINUTE,140 WATT CYCLE, THE EQUIPMENT MALFUNCTIONED AND STOPPED WORKING DUE TO A HIGH REFLECTIVE POWER MESSAGE. WHEN MOBILIZING THE ANTENNA, IT WAS OBSERVED THAT THE TIP WASN'T MOVING. UPON REMOVAL OF THE APPLICATOR, IT WAS OBSERVED THAT THE TIP WAS BROKEN. NO ACTIVE BLEEDING WAS OBSERVED IN THE CONTROLS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. ADDITIONAL INFORMATION: DEVICE WAS NOT REMOVED AND EXAMINED WHEN REPOSITIONED. NO ADJUNCT TOOLS WERE USED DURING THE PROCEDURE THE TIP WILL NOT BE REMOVED. DOCTOR HAS BEEN USING SOLERO SINCE 2022 TOTAL TIME FOR THE WHOLE PROCEDURE WAS FROM 2:00 P.M. TO 4:06 P.M. TWO LES

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22461849 ↗
• 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 19CM SOLERO APPLICATOR. A PATIENT WAS UNDERGOING A PERCUTANEOUS MW THERMOABLATION TREATMENT OF A NODULE IN THE KIDNEY. THE UNIT WAS SET FOR 6 MINUTES AT 140 WATTS. AFTER A 22 SECONDS, THE UNIT SHOWED A LOWER WATTAGE OF 111 WATTS. THE OPERATOR WITHDREW THE APPLICATOR AT WHICH TIME IT WAS OBSERVED THE TIP HAD DETACHED AND 3 PARTS WERE RETAINED IN THE PATIENT'S KIDNEY. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22371657 ↗
• MalfunctionJun 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER FACILITY EXPERIENCED A 19CM SOLERO PROBE TIP DETACHMENT DURING A PATIENT'S PERCUTANEOUS MICROWAVE ABLATION PROCEDURE OF THE LIVER. THE APPLICATOR WAS TESTED SUCCESSFULLY AT 100W FOR 10 SECONDS; THEREFORE, THE UNIT WAS SET AND THE PROCEDURE WAS STARTED. THE FIRST ABLATION WAS COMPLETED SUCCESSFULLY, AND THE APPLICATOR WAS INSPECTED AND FOUND TO BE WITHIN SPECIFICATION; HOWEVER, DURING THE SECOND ABLATION, THE PHYSICIAN OBSERVED THE GENERATOR'S REFLECTED ENERGY DECREASE. AT THAT TIME, THE TREATMENT WAS STOPPED, AND THE PROBE WAS REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS OBSERVED THAT THE TIP OF THE PROBE HAD DETACHED AND WAS IN THE PATIENT'S LIVER. THE PATIENT REQUIRED SURGICAL REMOVAL OF THE TIP AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE TOTAL ABLATION TIME WAS 4 MINUTES AT 100W AND 6 MINUTES AT 140W WITH A LESION SIZE GREATER THAN 5CM. THERE WAS NO DIFFICULTY NOTED WHEN PLACING OR REMOVING THE APPLICATOR FROM THE PATIENT AND NO ADJUST DEVICES WERE USED DURING THE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE A VERY EXPERIENCED USER OF 4 YEARS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22166695 ↗
• MalfunctionJun 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 19CM SOLERO APPLICATOR. DURING A PERCUTANEOUS LIVER TUMOR ABLATION PROCEDURE, THE SOLERO ABLATION NEEDLE EXPERIENCED A CERAMIC TIP BREAKAGE. AFTER UNPACKING A NEW APPLICATOR, A FUNCTIONAL TEST WAS PERFORMED AT 100]W FOR 30 SECONDS. THE NEEDLE FUNCTIONED NORMALLY AND WAS DEEMED SUITABLE FOR CLINICAL USE. THERE WAS NO RESISTANCE WHEN ADVANCING THE APPLICATOR AND NO ADJUNCT TOOLS WERE USED. THE FIRST ABLATION ON THE TARGET TUMOR WAS CONDUCTED AT A SETTING OF 100 W FOR 2 MINUTES AND WAS COMPLETED SUCCESSFULLY. A SECOND ABLATION ON ANOTHER TUMOR WAS THEN INITIATED. TO CONFIRM THE FUNCTION OF THE NEEDLE, A SECOND FUNCTIONAL TEST WAS PERFORMED BEFORE THE OFFICIAL ABLATION. IT FUNCTIONED NORMALLY, AND THE SECOND ABLATION WAS APPLIED AT 100 W FOR 2 MINUTES. WHEN APPROXIMATELY 1 MINUTE AND 26 SECONDS REMAINED, THE DISPLAYED OUTPUT WATTAGE DROPPED FROM 82 W TO 70 W IMMEDIATELY, AND THE "HIGH REFLECTED POWER" WARNING APPEARED. THE PHYSICIAN WAS INFORMED OF THE WARNING AND PULLED OUT THE NEEDLE TO CHECK. UPON REMOVAL, ONLY THE STAINLESS STEEL PORTION OF THE NEEDLE TIP WAS PRESENT, THE CERAMIC TIP WAS MISSING. THE BROKEN CERAMI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22166694 ↗
• MalfunctionMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. AFTER UNBOXING A NEW ABLATION PROBE, A FUNCTIONAL TESTING WAS PERFORMED AT 100W FOR 30 SECONDS. AT THAT TIME, THE PROBE FUNCTIONED NORMALLY AND WAS CONSIDERED AS SUITABLE FOR USE. THE FIRST ABLATION WAS THEN INITIATED WITH A SETTING OF 100W FOR 6 MINUTES, THE PROBE WAS PERCUTANEOUSLY PLACED, AND THE ABLATION WAS STARTED. HOWEVER, WHEN THE REMAINING ABLATION TIME WAS APPROXIMATELY 4 MINUTES AND 30 SECONDS, THE SYSTEM DISPLAYED AN ERROR MESSAGE: "HIGH REFLECTED POWER. REPOSITION APPLICATOR AND RETRY." IN RESPONSE, THE CABLE AND PUMP WERE RECONNECTED, AND THE SYSTEM WAS RESTARTED, BUT THE SAME ERROR MESSAGE CONTINUED TO APPEAR. IT WAS RECOMMENDED THE PHYSICIAN TO REMOVE THE PROBE AND CHECK FOR ANY ISSUES. AFTER THE REMOVAL, IT WAS DISCOVERED THAT THE CERAMIC PART OF THE TIP HAD BROKEN AT THE MIDPOINT (NOT AT THE JUNCTION BETWEEN THE CERAMIC AND STAINLESS STEEL). THE BROKEN CERAMIC TIP REMAINED INSIDE THE PATIENT. ALTHOUGH IT WAS SUGGESTED THAT THE PHYSICIAN USE A NEW PROBE TO COMPLETE THE PROCEDURE, THE PHYSICIAN DECLINED AND DETERMINED THAT THE PROCEDURE COULD NOT BE CONTINUED, THUS IT WAS TE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21977277 ↗
• MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A 19CM SOLERO APPLICATOR. THE PROCEDURE WAS PERFORMED PERCUTANEOUSLY VIA AN ACCESS IN THE AREA OF THE MEDIAN ABDOMINAL WALL. THE APPLICATOR WAS TESTED FOR 30 SECONDS AT 100 WATTS. THE APPLICATOR WAS THEN PLACED CENTRALLY IN LIVER SEGMENT 8 WITHOUT RESISTANCE OR TECHNICAL DIFFICULTIES (DISTANCE TO THE LIVER CAPSULE APPROX. 3 CM). THE UNIT WAS SET FOR 1 MINUTE AT 100 WATTS FOR AN INITIAL ABLATION CYCLE. THE APPLICATOR REMAINED IN THE PATIENT DURING THE ABLATION CYCLE WITHOUT MANIPULATION. THE ABLATION AREA WAS MONITORED BY CT DURING THE ENTIRE PROCEDURE, WHICH DETECTED THE BREAKAGE OF THE MWA TIP. NO ERROR CODES HAD DISPLAYED. AFTER THE TIP BROKE, THE PERFORMING SURGEONS IMMEDIATELY CONSULTED A SENIOR GENERAL SURGEON AND ANOTHER EXPERIENCED LIVER SURGEON. BOTH ADVISED COMPLETING THE PLANNED PROCEDURE WITH A SECOND PROBE TO ENSURE THE DESIRED CLINICAL OUTCOME. SURGICAL REMOVAL OF THE TIP, WHICH WOULD INVOLVE MAJOR SURGERY, WAS NOT CURRENTLY RECOMMENDED. IT WAS DECIDED TO ABLATE FOR AN ADDITIONAL 3 MINUTES AT 120 WATTS WITH A 14CM SOLERO APPLICATOR, COMPLETING THE PROCEDURE. THE PATIENT IS CURRENTLY IN STATIONARY CARE AND CLINICALLY OBSERVED. NO SPECI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21700169 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A 19CM SOLERO APPLICATOR. PRIOR TO THE PROCEDURE, THE APPLICATOR WAS SUCCESSFULLY TESTED AT 60 WATTS FOR 10 SECONDS. THE APPLICATOR WAS PERCUTANEOUSLY PLACED AND THE UNIT WAS SET AT 140 WATTS FOR 6 MINUTES. THE NEEDLE WAS ADVANCED EASILY USING A STRAIGHT PATH THROUGH THE ABDOMINAL WALL INTO THE LESION WITHOUT TORQUING OR MANIPULATING THE NEEDLE AROUND ANY STRUCTURES. THERE WAS ALSO NO RESISTANCE IN REMOVING THE APPLICATOR TO REMOVE THE NEEDLE FROM THE BODY. NO ADJUNCT TOOLS WERE USED. THE APPLICATOR FAILED AND THE ABLATION WAS HALTED AT 30 SECONDS INTO THE SINGLE ABLATION OF THE RENAL MASS. A "HIGH REFLECTED POWER" MESSAGE HAD DISPLAYED. IT WAS NOTED AT THAT TIME THE TIP HAD DETACHED AND WAS RETAINED. IT WAS DETERMINED TO NOT CONTINUE WITH THE PROCEDURE AND THE PATIENT WAS SCHEDULED FOR A PARTIAL NEPHRECTOMY TO REMOVE THE LESION AND THE TIP. THE DOCTOR HAS PERFORMED HUNDREDS OF MW PROCEDURES FOR MANY YEARS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21228613 ↗
• MalfunctionDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. A MWA CASE WAS SET TO BE PERFORMED PERCUTANEOUSLY AT100W, 4MIN BURN UNDER US AND CT GUIDANCE. THE LESION HAD LIPIODOL STAIN. THE SOLERO APPLICATOR WAS PREPARED AS PER THE IFU, POST FIRST BURN, THEY SET UP FOR 140W 2MINUTES. 50 SECONDS INTO THE BURN, A "HIGH REFLECTED POWER" MESSAGE DISPLAYED. THEY ATTEMPTED TO DO THREE MORE ABLATIONS WITH THE HIGH REFLECTED POWER ERRORS. THEN THE DOCTOR DECIDED TO FINISH AND REMOVED PROBE. IT WAS NOT IMMEDIATELY NOTED THE TIP HAD DETACHED BUT WAS NOTICED WHEN HE CUT THE PROBE FOR DISPOSAL. THE TIP WAS ALSO NOTED ON THE POST ABLATION IMAGING DUE TO THE LIPIODOL STAINING (ON SOFT TISSUE WINDOW). HE DETERMINED THAT IT WAS NOT AN ISSUE AS THE TIP WAS CERAMIC AND THE REMOVAL PROCEDURE WAS TOO INVASIVE; IT WAS LOWER RISK TO LEAVE THE TIP IN-SITU. THE DOCTOR HAS BEEN USING SOLERO PRODUCT FOR 8 YEARS. THE ABLATION SIZE WAS 3CM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21027163 ↗
• MalfunctionDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A 19CM SOLERO APPLICATOR. THE 1ST APPLICATOR WAS SUCCESSFULLY TESTED AT 100W FOR 30 SECONDS. IT WAS LAPAROSCOPICALLY PLACED WITH NO DIFFICULTY IN THE LIVER AND THE UNIT WAS SET FOR 4 MINUTES AT 100WATTS. TWO ABLATION CYCLES WERE PERFORMED WITHOUT REMOVING THE APPLICATOR. SUBSEQUENTLY, A NEW NEEDLE (SAME BATCH NUMBER) WAS OPENED, AND ANOTHER ABLATION WAS PERFORMED AT 100W-4MIN TO COMPLETE THE OPERATION. THE SITUATION OCCURRED WHEN THE SECOND NEEDLE WAS SET TO 100W. THE WATTAGE DROPPED TO 75W 50 SECONDS AFTER THE START. THEN THE MACHINE DISPLAYED A HIGH-ENERGY FEEDBACK MESSAGE. THE NEEDLE WAS IMMEDIATELY REMOVED, AND IT WAS FOUND THAT THE CERAMIC NEEDLE HAD BROKEN INTO THE TUMOR. THE TIP REMAINS INSIDE THE PATIENT AS THE DOCTOR WAS UNABLE TO REMOVE IT. THE DOCTOR HAS BEEN USING SOLERO PRODUCT FOR 3 YEARS. THE TOTAL TIME OF THE ABLATION WAS 8 MINUTES AND THE ABLATION SIZE WAS 3.2CM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21027160 ↗
• MalfunctionNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION: A 22G NEEDLE WAS UTILIZED AS AN ADJUNCT DEVICE TO AID IN DETERMINING THE LEVEL OF CRITICAL STRUCTURES IN THE LIVER. THE TOTAL ABLATION TIME WAS REPORTED AS 8MIN 140W (2X4 MIN 140W), WITH AN ABLATION ZONE OF 3/5.5CM. THE ANTENNA WAS RETAINED COMPLAINT IN ITS ORIGINAL PACKAGING. PRIOR TO THE PROCEDURE, THE APPLICATOR WAS TESTED SUCCESSFULLY AT 100W, FOR 10 SECONDS AND THE PHYSICIAN IS AN EXPERIENCED USER OF 5-10 YEARS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20707152 ↗
• MalfunctionOct 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19 CM SOLERO APPLICATOR. THE CUSTOMER CLAIMS THAT THE CERAMIC TIP OF THE SOLERO APPLICATOR BROKE OFF IN LIVER AT THE END OF A CT GUIDED MICROWAVE ABLATION PROCEDURE. CASE DETAILS - CT GUIDED PERCUTANEOUS ABLATION OF LIVER (HCC) IN WHICH TWO SEPARATE LESIONS WERE TREATED. THE APPLICATOR WAS TESTED PRIOR TO USE AND PLACED WITH NO RESISTANCE OR DIFFICULTY. 2 ABLATIONS WERE PERFORMED. FIRST LESION WAS BURNED TWICE, ONCE FOR 4 MINUTES AT 140 W AND AGAIN FOR 4 MORE MINUTES AT 100 W. THE SECOND LESION WAS ALSO BURNED TWICE, BOTH TIMES THE LESION WAS TREATED FOR 2 MINUTES AT 140 W. NO ERROR CODES APPEARED DURING THE PROCEDURE. THE APPLICATOR WAS WITHDRAWN AND INSPECTED BETWEEN THE 2ND AND 3RD ABLATIONS. LOOKED NORMAL WHEN REPOSITIONING BETWEEN LIVER SEGMENTS 5 AND 8 TO TARGET THE SECOND LESION. THEY BELIEVE THE TIP DETACHED DURING THE LAST ABLATION. A PARACENTESIS PROCEDURE WAS ALSO PERFORMED AT THE SAME TIME AS THE MWA PROCEDURE. TREATING PHYSICIANS, DR. (B)(6) (RADIOLOGIST) AND DR. (B)(6) (5TH YR RESIDENT), STATE THAT THE ABLATION TREATMENTS WERE BOTH SUCCESSFULLY COMPLETED. THEY ALSO REPORT THAT THE ISSUE WAS NOT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20514311 ↗
• MalfunctionSep 4, 2024Detachment 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. DURING THE PROCEDURE, THE TIP DETACHED FROM THE APPLICATOR AND WAS RETAINED IN THE PATIENT'S LUNG. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20134292 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE APPLICATOR WAS TESTED FOR 10 SECONDS AT 100 WATTS PRIOR TO PERCUTANEOUS INSERTION WITH NO REPORTED ISSUES. THE UNIT WAS SET FOR 140 WATTS FOR 6 MINUTES FOR THE FIRST ABLATION CYCLE. THE SECOND ABLATION WAS PERFORMED AT 40 WATTS FOR 4 MINUTES. THE UNIT WAS THEN SET FOR 140 WATTS FOR 4 MINUTES. WHILE ABLATING THE LARGE 5X4 RENAL LESION, THE PROBE TIP BROKE OFF IN THE PATIENT. THEY HAD ABLATED WITH THE SAME PROBE 2 TIMES AND ON THE 3RD ABLATION THEY DID NOT NOTICED ANY CHANGES ON THE CT IMAGE. WHEN THEY REMOVED THE PROBE, THEY NOTICED THE TIP WAS MISSING AND IT WAS ABLE TO BE SEEN ON THE CT SCAN. THE PATIENT IS NOT A SURGICAL CANDIDATE, SO THEY DETERMINED TO LEAVE THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER APPLICATOR. PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. PHYSICIAN THOUGHT HE MIGHT HAVE USED EXCESS OR LATERAL FORCE. ADDITIONAL INFORMATION: NO ERROR MESSAGES WERE RECEIVED DURING THE PROCEDURE. THE APPLICATOR WAS NOT REMOVED AND INSPECTED BETWEEN ABLATION CYCLES. THE DOCTOR HAS BEEN USING SOLERO PRODUCT FOR GREATER THAN 4 YEARS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20012727 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL EVENT INFORMATION: THE PHYSICIAN PERFORMED THE PROCEDURE, AND IT WENT UNEVENTFULLY. THE PHYSICIAN DID AN ABLATION OF THE LOWER PORTION OF THE TUMOR AND REPOSITIONED THE PROBE. AFTER ABLATING THE UPPER PORTION OF THE TUMOR, THE NEEDLE WAS REMOVED AND DISCARDED. POST ABLATION IMAGING WAS PERFORMED, AND THE PHYSICIAN NOTICED 4-5 FRAGMENTS IN THE ABLATION ZONE WITH THE LARGEST MEASURING 4MM X 2MM. THE OTHERS WERE 2-3MM OR SMALLER. THE PHYSICIAN CONTACTED THE REP. WHO WAS THERE FOR THE PROCEDURE. PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20012379 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE PROCEDURE WAS AN OPEN SURGERY SETTING.APPLICATOR WAS USED IN AN INTRAOPERATIVE SETTING. PATIENT HAD 4 COLORECTAL METASTASES IN SEGMENT VIII. DUE TO DIFFICULTY OF ACCESS, AN ABLATION OF ALL 4 METASTASES WERE PLANNED. FIRST PLAN WAS TO USE ONE NEEDLE ON ALL 4 LESIONS BUT DUE TO DIFFICULTY OF ACCESS, WE DECIDED ON USING 1 NEEDLE FOR THE FIRST 2 LESIONS AND ANOTHER NEEDLE FOR THE REMAINING 2. WE ABLATED THE FIRST TUMOUR WITH 2MIN 60W ABLATION SUCCESSFULLY. THE FOLLOWING 2 LESIONS WERE CLOSE TO EACH OTHER SO IN ORDER TO NOT LOSE VISUALIZATION AFTER ABLATION OF THE FIRST TUMOUR WE INSERTED 2 NEEDLES AND ABLATED THE TUMOURS ONE AT A TIME. FIRST ABLATION WAS SUCCESSFUL (DONE WITH FIRST NEEDLE) AND SECOND ABLATION WAS SUCCESSFUL AS WELL (DONE WITH THE NEEDLE LOT 5810675). BOTH ABLATIONS WERE DONE WITH 2MIN 60W SETTING. WE REMOVED THE NEEDLE LOT 5810675 (VISUAL INSPECTION SHOWED NO SIGN OF DAMAGE IN THE TIP) AND INSERTED IT INTO THE LAST TUMOUR. WE PERFORMED THE LAST ABLATION WITH 6MIN 140W SETTING BUT NOTICED ON ULTRASONIC IMAGING THAT NO ABLATION WAS BEING DETECTED. WE RAN ANOTHER ABLATION WITH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19509067 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. PRIOR TO THE PROCEDURE, THE APPLICATOR WAS SUCCESSFULLY TESTED IN 20ML NORMAL SALINE FOR 100W FOR 30SEC. THE PROCEDURE WAS PERFORMED PERCUTANEOUSLY WITH NO NOTICEABLE DIFFICULTY WHEN PLACEING THE APPLICATOR. NO ADJUNCT TOOLS WERE USED DURING THE PROCEDURE. THE DOCTOR COMPLETED TWO ABLATIONS AT 100W FOR 4 MINUTES EACH. SHE THEN ATTEMPTED A THIRD ABLATION AT 140W FOR 3 MINUTES. HOWEVER, APPROXIMATELY 20 SECONDS INTO THE ABLATION, THE GENERATOR DISPLAYED A "HIGH REFLECTED POWER" WARNING. ATTEMPTS WERE MADE TO RESOLVE THE ISSUE, AND IT WAS DECIDED TO CHANGE THE APPLICATOR FOR A NEW ONE. WHEN THE APPLICATOR WAS WITHDRAWN, IT WAS DISCOVERED THAT THE CERAMIC TIP HAD DETACHED AND REMAINED INSIDE THE PATIENT'S BODY. THE APPLICATOR HAD NOT BEEN REMOVED AND INSPECTED BETWEEN ABLATIONS. THE DOCTOR DID NOT ATTEMPT TO REMOVE THE TIP AS IT WAS NOT CONSIDERED MEDICALLY NECESSARY. THE ABLATION SIZE WAS 2CM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18836904 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. PRIOR TO INSERTION, THE APPLICATOR WAS SUCCESSFULLY TESTED AT 100 WATTS FOR 30 SECONDS IN 140ML OF NORMAL SALINE. THE PROCEDURE WAS PERCUTANEOUS AND PERFORMED UNDER ULTRASOUND. THERE WERE NO ADJUNCT TOOLS USED DURING THE PROCEDURE AND THERE WAS NO ISSUES OR RESISTANCE WHEN PLACING THE APPLICATOR. THE DOCTOR INITIATED THE FIRST ABLATION AT 140W FOR 6 MINUTES. WITH 43 SECONDS REMAINING TO COMPLETE THE ABLATION, THE GENERATOR DISPLAYED "HIGH REFLECTED POWER". THE DOCTOR DEEMED THE ABLATION AREA SUFFICIENT AND WITHDREW THE APPLICATOR. AT THAT TIME, IT WAS OBSERVED THAT THE APPLICATOR WAS DAMAGED, WITH THE CERAMIC TIP SEPARATED AND LEFT INSIDE THE PATIENT'S BODY. THE APPLICATOR HAD NOT BEEN WITHDRAWN AND INSPECTED PRIOR TO THIS. IT WAS DETERMINED TO NOT REMOVE THE TIP AS IT WAS NOT CONSIDERED MEDICALLY NECESSARY. THE ABLATION/TUMOR SIZE IS 4.4 *5.4 CM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18836887 ↗

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-2436-2021 · Jul 20, 2021 · Terminated
  Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
• 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-2439-2021 · Jul 20, 2021 · Terminated
  Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
• 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-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
• 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-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-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