Solero 12740000USRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H78712740000US0), received between Sep 7, 2023 and Dec 20, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2025Temperature Problem; Temperature Problem

  A DISTRIBUTOR REPRESENTATIVE, WHO WAS IN ATTENDANCE FOR THE CASE, REPORTED THE FOLLOWING ISSUE WITH A SOLERO GENERATOR: THE PHYSICIAN COMPLETED A 4 MINUTE BURN AT 120 W ON A KIDNEY. THE TRACK KEY WAS UNRESPONSIVE FOLLOWING THE BURN. THEY TURNED THE GENERATOR OFF AND ON WHEN IT DISPLAYED ERROR 209. THEY TURNED THE UNIT OFF AGAIN, CHANGED THE SALINE AND THE GENERATOR STILL HAD THE ERROR MESSAGE. MULTIPLE ATTEMPTS WERE MADE TO CLEAR THE ERROR CODE. THE UNIT STARTED UP CORRECTLY. THE PROBE WAS CONNECTED AND NO ERROR DISPLAYED. IMMEDIATELY UPON TRYING TO PERFORM A TEST @100W FOR 10 SECONDS, THE SYSTEM SHOWED A HIGH REFLECTED POWER MESSAGE. EVEN AFTER REMOVING THE FIRST PROBE, AND CONSEQUENTLY 2 OTHER PROBES, DOING SHUTDOWNS AND RESTARTS, SETTING DIFFERENT POWER LEVELS, AND CLEANING THE PROBE CASSETTE CONNECTORS MORE THAN ONCE, IT DID NOT CLEAR THE ERROR MESSAGE. THEY ALSO TRIED POSITIONING THE FIRST PROBE IN HEALTHY LIVER TISSUE, TO SEE IF THE PROBE WOULD WORK IF IN TISSUE, WITH THE SAME RESULT. THE PATIENT WAS UNDER ANESTHESIA FOR 3 MORE HOURS THAN NEEDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SOLERO UNIT AND ONE 3X3CM LESION WAS TREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858801 ↗
• MalfunctionDec 17, 2025Display or Visual Feedback Problem; No Visual Prompts/Feedback; Display or Visual Feedback Problem; No Visual Prompts/Feedback

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOLERO GENERATOR. WHEN PREPARING FOR A MICROWAVE ABLATION PROCEDURE OF THE KIDNEY, AFTER TURNING ON THE UNIT, AND CONNECTING THE 14CM SOLERO APPLICATOR, THE SCREEN FROZE. IT WOULD NOT RESPOND TO ANY MANUAL COMMANDS, EVEN AFTER STARTING THE SYSTEM SEVERAL TIMES. IT WAS NECESSARY TO SUSPEND THE PROCEDURE. IT WAS REPORTED THE PATIENT HAD BEEN UNDER GENERAL ANESTHESIA AND DID NOT RECEIVE ANY TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826039 ↗
• MalfunctionMar 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOLERO MTA GENERATOR. THE PUMP DIDN'T TURN ON DURING POWER UP. IN THE DISPLAY IT APPEARED "INVALID SPEED PUMP". THEY TRIED TURNING IT OFF AND ON WITH THE SAME RESULT. THEY MANUALLY TURNED THE WHEEL AND THE PUMP STARTED. THE SAME HAPPENED DURING TWO CASES. NEXT, IT DIDN'T REGISTER THE SOLERO APPLICATOR WHEN THEY PLUGGED IT IN, BUT THEY WERE ABLE TO MAKE THE ABLATIONS. THE TOUCH SCREEN WAS NOT RESPONDING WELL (SOMETIMES NOT RESPONDING TO TOUCH). THE SWITCH IN THE BACK MUST BE SWITCHED QUICKLY OTHERWISE IT SPARKS. THE DOCTOR REPORTED HE HAD OBSERVED ONE SHORT SPARKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677702 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED AN ADVERSE PATIENT EFFECT WHEN USING A SOLERO MTA GENERATOR. THE PATIENT PRESENTED FOR A MICROWAVE PROCEDURE FOR A KIDNEY CUTANEOUS METASTAS. THE SETTINGS ON THE UNIT WERE 120W FOR 6 MINUTES. THE APPLICATOR WAS NOT REMOVED OR REPOSITIONED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED ISSUES OR PRODUCT MALFUNCTIONS. WHEN THE MW ABLATION WITH HYDRODISSECTION WAS COMPLETED, IT WAS NOTED THE PATIENT HAD SUSTAINED A 2X2X2CM BURN ON THE SKIN. MEDICAL TREATMENT FOR THE BURN WAS PERFORMED AT A DIFFERENT WARD. ACCORDING TO THE PRODUCT SPECIALIST, THIS EVENT IS NOT A DEFECT OF THE PRODUCT, BUT RATHER AN INCIDENT THAT RESULTED IN PATIENT EFFECT.

  Patient problems: Burn(s)

  MAUDE report 21409586 ↗
• MalfunctionOct 10, 2024Failure to Power Up; Failure of Device to Self-Test; Failure to Power Up; Failure of Device to Self-Test

  ADDITIONAL INFORMATION: GENERATOR WAS TURNED ON PRIOR TO ANAESTHETIZING THE PATIENT, HOWEVER, THE SCREEN HAD NOT BEEN TOUCHED. ONCE PATIENT WAS ASLEEP AND APPLICATOR WAS ATTACHED, THE TEAM WENT TO RUN A TEST ON AN APPLICATOR AND IT WAS FOUND THAT THE TOUCH SCREEN WAS NOT WORKING.THE NEEDLE HAD NOT BEEN PLACED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415988 ↗
• MalfunctionSep 17, 2024Sparking; Sparking

  A DISTRIBUTOR REPORTED AN ISSUE WITH A SOLARO MTA GENERATOR. A SOLERO DEVICE BROKE DOWN IN ONE OF THE HOSPITALS, MOST LIKELY DUE TO A BLOWN FUSE. ADDITIONAL INFORMATION FROM CNF RECEIVED 09/09/2024: SOLERO MTA SYSTEM WAS PLUGGED IN TO WALL OUTLET AND AN AUDIBLE BANG WAS HEARD AND SOME SPARKS SHOT OUT OF THE MACHINE. AFTER THIS THE SYSTEM WOULD NOT TURN ON EVEN WHEN PLUGGED IN TO ANOTHER OUTLET. NO HARM WAS DONE TO THE PATIENT AS THEY HAD ANOTHER COMPETITORS MACHINE THEY COULD USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235543 ↗
• MalfunctionSep 7, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  AN ANGIODYNAMICS REGIONAL MANAGER REPORTED AN ISSUE WITH A SOLERO MTA GENERATOR. THE CUSTOMER'S GENERATOR CONTINUES TO FAIL. THE CLINICAL SPECIALIST, PRESENT DURING THE CASE, STATED THAT GENERATOR DISPLAYED "APPLICATOR NOT RECOGNIZED" AND THE DISPLAY SCREEN WAS FROZEN. THEY CONNECTED A 29CM PROBE, A SECOND 29CM PROBE AND THEN A 19CM PROBE WITH NO CHANGE. THEY ALSO CONNECTED THE GENERATOR TO ANOTHER POWER OUTLET WITH NO CHANGE. THEY PERFORMED MULTIPLE RESTARTS OF THE GENERATOR THROUGHOUT THIS PROCESS. THE GENERATOR FINALLY RECOGNIZED A PROBE AND THE PROCEDURE WAS COMPLETED/TREATMENT PROVIDED. THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA DURING THIS ONE HOUR DELAY IN STARTING UP THE GENERATOR. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE DUE TO PATIENT SAFETY RISK, AS THE PATIENT WAS UNDER ANESTHESIA FOR GREATER THAN 30 MINUTES AS CONSIDERED NORMAL FOR THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699540 ↗

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-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-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 Refurbish
• 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 C
• 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 Cata
• 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: 1
• 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 Ca