Solero 700106003-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI H787700106003US0), received between Dec 15, 2021 and Jun 23, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR, IN ATTENDANCE FOR THE CASE, REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 29CM SOLERO APPLICATOR. A PATIENT PRESENTED FOR A LAPAROSCOPIC MICROWAVE ABLATION OF THE LIVER, SEGMENT 6. THE APPLICATOR WAS TESTED AT 100 WATTS FOR 10 SECONDS WITH NO ISSUES. THE APPLICATOR WAS CONNECTED TO THE UNIT, AND THE DOCTOR PLACED THE APPLICATOR INSIDE THE LESION. THE UNIT WAS SET FOR 6 MINUTES @ 140 WATTS. ONCE THE SETTING WAS CONFIRMED, THE ABLATION WAS STARTED. WITHIN 2SEC INTO THE ABLATION, 5:58MIN, THE ERROR APPEARED - HIGH REFLECTED POWER. THE SALES REP THEN REQUESTED THAT THE PROBE BE REPOSITIONED. THEY REPOSITIONED THE PROBE AND TRIED AGAIN, BUT THE SAME MESSAGE APPEARED. THE DOCTOR THEN REPOSITIONED THE PROBE 4X TIMES MORE, INCLUDING INTO HEALTHY LIVER TISSUE, AND EVERY TIME THE SAME ERROR APPEARED. THEY DECREASED THE WATTAGE TO 100 WATTS IN AN ATTEMPT TO CLEAR THE ERROR BUT WERE UNSUCCESSFUL. AT THIS TIME, IT WAS SUGGESTED TO EXCHANGE THE APPLICATOR. UPON WITHDRAWAL OF THE PROBE, IT WAS OBSERVED THE CERAMIC TIP HAD DETACHED INSIDE OF THE PATIENT'S LIVER. THE TIP WAS CLEARLY VISIBLE ON SONAR SITUATED INSIDE THE PATIENT'S LIVER. THE PROCEDURE WAS COMPLETED WITH A NEW

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22308175 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH A 29CM SOLERO APPLICATOR. THE APPLICATOR WASLAPROSCOPICALLY PLACED WITHOUT PRIOR TESTING. DURING A LIVER MICROWAVE ABLATION PROCEDURE, THE FIRST LESION WAS ABLATED FOR 2 MINUTES AT 60W. WHEN THE END USER REMOVED THE APPLICATOR, THE WHITE TIP WAS OBSERVED TO HAVE FRACTURED OFF AND WAS LOCATED UNDER THE PATIENT'S SKIN. THE TIP WAS REMOVED USING FORCEPS. NO ERROR MESSAGES HAD DISPLAYED. SINCE THE PROCEDURE HAD NOT BEEN COMPLETED, IT WAS NECESSARY TO OPEN A NEW APPLICATOR TO CONTINUE. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EFFECTS BECAUSE OF THIS INCIDENT. ADDITIOANL INFORMATION: THEPHYSICIAN HAS BEEN USING SOLERO PRODUCT FOR 1.5 YEARS. THIS IS THE FIRST TIP DETACH OCCURRENCE FOR HIM. ABLATION SIZE WAS 2.2 X 2.6CM TOTAL TIME OF ABLATION WAS 4 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22289508 ↗
• MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED TO BFARM ABOUT AN ISSUE THEY EXPERIENCED WITH A 29CM SOLERO APPLICATOR. PRIOR TO THE PROCEDURE, THE APPLICATOR WAS TESTED FOR 10 SECONDS AT 140WATTS. THE UNIT WAS SET FOR 140 WATTS FOR 6 MINUTES, AND THE APPLICATOR WAS LAPROSCOPICALLY PLACED WITH NO DIFFICULTY. NO ADJUNCT TOOLS WERE USED. 1 ABLATION CYCLE WAS COMPLETED, AND THE APPLICATOR WAS WITHDRAWN AND INSPECTED AFTER THE CYCLE. DURING THE NEXT ABLATION CYCLE, THE UNIT DISPLAYED AN ERROR MESSAGE "REPOSITION ELECTRODE" (HIGH REFLECTIVE POWER) WITH 2:06 MINUTES REMAINING. WHEN WITHDRAWING THE APPLICATOR, IT WAS NOTICED THAT THE CERAMIC TIP WAS MISSING. CONTROL CT SHOWED THAT THE CATHETER TIP REMAINED IN THE ABLATED AREA WITHIN THE LIVER. THE PROCEDURE WAS NOT COMPLETED. THE PHYSICIAN HAS BEEN USING THE SOLERO PRODUCT FOR GREATER THAN 5 YEARS AND HAS PERFORMED GREATER THAN 1000 ABLATIONS. CT IMAGING SHOWED SUFFICIENT SIZE FOR A COMPLETE ABLATION OF THE TUMOR AROUND (5CM DIAMETER, NOT EXACTLY SPHERICAL).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21527976 ↗
• MalfunctionDec 27, 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 29CM SOLERO APPLICATOR. WHILE PERFORMING A LIVER ABLATION CASE WITH A SOLERO PROBE, THE DOCTOR WAS REPOSITIONING THE SOLERO PROBE AND WHEN HE PULLED THE PROBE OUT TO REPOSITION THE CERAMIC TIP OF THE PROBE BROKE OFF AND FELL DOWN INTO THE PATIENT'S ABDOMEN. THEY WERE UNABLE TO LOCATE THE TIP AND IT WAS LEFT INSIDE THE PATIENT ABDOMEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21027162 ↗
• MalfunctionDec 27, 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 29 CM SOLERO APPLICATOR. DURING PREPARATION, THE APPLICATOR WAS SUCCESSFULLY TESTED AT 100W FOR 10 SECONDS. THE APPLICATOR WAS LAPROSCOPICALLY PLACED. THE UNIT HAD BEEN SET FOR 140W FOR 4 MINUTES. AFTER THE THIRD COMPLETED ABLATION, THE PROBE WAS REMOVED FROM LIVER WITHOUT TIP (SEPARATED AT FEEDPOINT.) NO ERROR MESSAGES HAD BEEN RECEIVED AND THE APPLICATOR HAD NOT BEEN REMOVED AND INSPECTED BETWEEN ABLATIONS. ALONG WITH THE APPLICATOR, GRASPERS AND A CAMERA SCOPE WERE USED IN THE PROCEDURE AS WELL. THE TIP WAS IN THE ABLATED LIVER TISSUE, THEREFORE IT WAS LEFT IN THE PATIENT AND WILL NOT BE REMOVED PER POLICY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SOLERO APPLICATOR. THE PHYSICIAN HAS BEEN USING SOLERO PRODUCT FOR MORE THAN 5 YEARS ALONG WITH ANGIODYNAMICS' HABIB AND RFA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21027159 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER, WHO WAS IN ATTENDANCE FOR THE PROCEDURE, REPORTED AN ISSUE WITH A 29CM SOLERO APPLICATOR. THE APPLICATOR WAS NOT TESTED PRIOR TO THE PROCEDURE. THE TM HAD SET THE UNIT FOR 140W FOR SIX MINUTES. THE PROCEDURE WAS PERFORMED LAPAROSCOPICALLY. THE DOCTOR USED A METAL "TUNNELER" TO TUNNEL TO THE LIVER, AND THEN INSERTED THE APPLICATOR THROUGH THE METAL DEVICE WITH SOME DIFFICULTY. IT WAS REPORTED THAT HE KEPT INSERTING AND WITHDRAWING THE APPLICATOR TO LINE IT UP WITH THE AREA HE WANTED TO BURN. HE PERFORMED THREE BURNS, WITHDRAWING IT EACH TIME TO REPOSITION IT, BUT NO EXAMINATION OF THE TIP WAS DONE AT THOSE TIMES. SHE SAID THAT HE WOULD "POKE AROUND" INSIDE THE PATIENT EACH TIME HE WITHDREW THE APPLICATOR. HE ALSO ASKED HER TO RESTART THE TIME TO SIX MINUTES REGARDLESS OF HOW MUCH TIME REMAINED ON THE UNIT. THIS WOULD ADD ANOTHER 6 MINUTES TO THE AMOUNT OF BURN TIME HE HAD ALREADY USED. SHE WAS UNABLE TO PROVIDE THE EXACT TOTAL AMOUNT OF TIME THAT THEY ENDED UP USING. SHE SUGGESTED SEVERAL TIMES TO EXCHANGE THE APPLICATOR, HOWEVER THOSE SUGGESTIONS WERE DISREGARDED. WHEN HE WITHDREW THE METAL "TUNNELER" SHE SAID IT LOOKED BENT. SHE SAID AFTER MULTIPLE BURNS, AN

  Patient problems: Foreign Body In Patient

  MAUDE report 17765993 ↗
• MalfunctionOct 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE 29CM SOLERO APPLICATOR BROKE DURING A LAPAROSCOPIC LIVER ABLATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW APPLICATOR AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598143 ↗
• MalfunctionMar 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED AN ISSUE WITH A 29CM SOLERO APPLICATOR. THE APPLICATOR WAS PLACED THROUGH THE LAPAROSCOPIC HOLE, IN A BK ULTRASOUND PROBE,AND TESTED SUCCESSFULLY AT 100W FOR 20 SECONDS. IT WAS NOTED THAT USE OF THE BK ULTRASOUND PROBE, IN CONJUNCTION WITH THE SOLERO APPLICATOR, IS A COMMON PRACTICE FOR THIS PHYSICIAN, WHO WAS DESCRIBED AS WELL-EXPERIENCED WITH SOLERO DEVICES. AFTER SUCCESSFUL TESTING, THE GENERATOR WAS THEN SET TO 140W FOR 3 MINUTES AND THE ABLATION WAS INITIATED. AFTER APPROXIMATELY 15 SECONDS, SMOKE WAS NOTED TO BE EMANATING FROM THE TIP OF THE APPLICATOR AND THE GENERATOR DISPLAYED A "HIGH REFLECTED POWER" ERROR MESSAGE. AT THIS TIME, IT WAS NOTED THAT THE TIP HAD DETACHED CLEANLY, IN 2 PIECES, FROM THE APPLICATOR AND REMAINED INSIDE OF THE PATIENT'S LIVER. THE CONDITION OF THE LIVER WAS REPORTED TO HAVE APPEARED "NORMAL," WITH NO EVIDENCE OF CIRRHOSIS. THE TIP FRAGMENTS WERE REMOVED THROUGH THE EXISTING LAPAROSCOPIC INCISION, WITH MINIMAL DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS ISSUE. THE PHYSICIAN DOES NOT BELIEVE THAT THIS EVENT WAS THE RESULT OF A

  Patient problems: Foreign Body In Patient

  MAUDE report 13840062 ↗
• MalfunctionDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 29 CM SOLERO APPLICATOR. THE APPLICATOR WAS SALINE TESTED AND PRIMED PER PROTOCOL. THE UNIT WAS SET FOR 140WX2 MINUTES. THE APPLICATOR WAS PLACED LAPAROSCOPICALLY IN SEGMENT 2 OF THE LIVER WITH NO ISSUES DURING INSERTION, THE PROCEDURE WAS PERFORMED USING ULTRASOUND AND NO ERROR MESSAGES DISPLAYED PRIOR TO THE FIRST ABLATION. THE FIRST ABLATION WAS PERFORMED FOR A TOTAL OF 2 MINUTES. WHEN WITHDRAWING THE APPLICATOR, IT WAS NOTED THE CERAMIC TIP HAD DETACHED AND REMAINED INSIDE THE PATIENT'S LIVER TUMOR. THE TREATING PHYSICIAN DETERMINED IT WAS TOO RISKY TO ATTEMPT TO TRY AND REMOVE THE TIP, AT THIS TIME, IT WAS DETERMINED TO ABORT THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13011152 ↗

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-2439-2021 · Jul 20, 2021 · Terminated
  Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
• Z-2437-2021 · Jul 20, 2021 · Terminated
  Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
• Z-2438-2021 · Jul 20, 2021 · Terminated
  Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
• 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-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-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