Accurian AG1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000140809), received between Sep 13, 2019 and Aug 4, 2020 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

6 other recalls cover devices cleared under the same FDA submission (K181864); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A RADIO FREQUENCY ABLATION (RFA) DEVICE. IT WAS REPORTED THAT ON (B)(6) 2020, WHILE DOING A LESION ON A PATIENT WITH "DRY SCALY" SKIN, THE GENERATOR DISPLAYED A CODE OF F07. THE HCP USED ANOTHER GENERATOR, AND THE SAME CODE APPEARED WHEN THEY BEGAN TO DO A LESION. THEY THEN HAD TO FINISH THE LESION USING A COMPETITOR'S GENERATOR. WHEN THEY TOOK THE GROUNDING PAD OFF OF THE PATIENT, THEY NOTICED THERE WAS A LOT OF DEAD/DRY TISSUE ON THE GROUNDING PAD. IT WAS NOTED THAT TWO ADDITIONAL CASES TOOK PLACE AFTER THIS PATIENT, AND THE F07 CODE DID NOT APPEAR DURING THOSE TWO CASES. TECHNICAL SERVICES REVIEWED THAT THE F07 CODE COULD INDICATE AN OPEN CIRCUIT DUE TO THE TISSUE BLOCKING THE CURRENT FROM CIRCULATING, AND REVIEWED REPOSITIONING THE CANNULA/NEEDLE COULD HAVE BEEN TRIED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS CLARIFIED THAT THE ORIGINAL GENERATOR WAS USED ON THE FOLLOWING TWO CASES, AND A NEW GROUNDING PAD WAS USED EACH TIME. IT WAS REPORTED THAT THE GENERATORS WOULD NOT BE RETURNED FOR ANALYSIS AS THE HCP DID NOT WANT TO HAVE T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10362223 ↗
• MalfunctionAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A RADIO FREQUENCY ABLATION (RFA) DEVICE. IT WAS REPORTED THAT ON (B)(6) 2020, WHILE DOING A LESION ON A PATIENT WITH "DRY SCALY" SKIN, THE GENERATOR DISPLAYED A CODE OF F07. THE HCP USED ANOTHER GENERATOR, AND THE SAME CODE APPEARED WHEN THEY BEGAN TO DO A LESION. THEY THEN HAD TO FINISH THE LESION USING A COMPETITOR'S GENERATOR. WHEN THEY TOOK THE GROUNDING PAD OFF OF THE PATIENT, THEY NOTICED THERE WAS A LOT OF DEAD/DRY TISSUE ON THE GROUNDING PAD. IT WAS NOTED THAT TWO ADDITIONAL CASES TOOK PLACE AFTER THIS PATIENT, AND THE F07 CODE DID NOT APPEAR DURING THOSE TWO CASES. TECHNICAL SERVICES REVIEWED THAT THE F07 CODE COULD INDICATE AN OPEN CIRCUIT DUE TO THE TISSUE BLOCKING THE CURRENT FROM CIRCULATING, AND REVIEWED REPOSITIONING THE CANNULA/NEEDLE COULD HAVE BEEN TRIED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS CLARIFIED THAT THE ORIGINAL GENERATOR WAS USED ON THE FOLLOWING TWO CASES, AND A NEW GROUNDING PAD WAS USED EACH TIME. IT WAS REPORTED THAT THE GENERATORS WOULD NOT BE RETURNED FOR ANALYSIS AS THE HCP DID NOT WANT TO HAVE T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10362199 ↗
• MalfunctionJul 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  2020-(B)(6), SNOW RTG0055209 (HCP, REP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A RADIOFREQUENCY ABLATION (RFA) SYSTEM. IT WAS REPORTED THAT THERE WAS A F07 RF BOARD HARDWARE FAILURE MESSAGE ON THE GENERATOR. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. 2020-(B)(6), SNOW RTG0055209, E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP HAD THE HCP RESTART THE GENERATOR AGAIN. IT WAS REPORTED THAT WHILE THEY WERE IN EITHER THE SENSORY OR MOTOR TESTING MODES, EVERYTHING WAS FINE. WHEN THEY GOT TO THE ACTUAL ABLATION, THEY SAW THE F07 ERROR MESSAGE. THE ACCOUNT HAD A BACKUP GENERATOR AND SO THEY TRIED THE SAME THING WITH THAT AND THE SAME ISSUE OCCURRED WHILE IN THE PROCEDURE. THE HCP GOT FRUSTRATED, SO THEY KEPT THE GROUNDING PAD ON AND USED AND OLDER RFA SYSTEM FROM A COMPETITOR, AND EVERYTHING WORKED FINE. IT WAS REPORTED THAT THE HCP WANTED TO HAVE THE GENERATOR REPLACED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. 2020--(B)(6), E2 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP DIDN'T KNOW TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10279784 ↗
• MalfunctionJun 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A RADIOFREQUENCY ABLATION (RFA) SYSTEM. IT WAS REPORTED THAT THE HCP RECEIVED A NEW REPLACEMENT GENERATOR AND WAS GETTING CONTINUOUS F07 ERRORS WHEN ATTEMPTING MOTOR AND SENSORY STIMULATION. THE MANUFACTURER REPRESENTATIVE FOLLOWED THE TROUBLESHOOTING STEPS ON THE GENERATOR SCREEN AND ERROR PERSISTED. IT WAS NOTED THAT THEY WERE USING THE CORRECT GROUNDING PAD. IT WAS ALSO REPORTED THAT AN E41 ERROR WAS DISPLAYED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. ON (B)(6) 2020, SNOW (B)(4) UPDATE (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS INDICATED THAT THE HCP WANTED TO HAVE THE WHOLE SYSTEM REPLACED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10112839 ↗
• MalfunctionFeb 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A RADIOFREQUENCY ABLATION (RFA) SYSTEM. IT WAS REPORTED THAT THE GENERATOR WAS DISPLAYING A F07 BOARD HARDWARE FAILURE. IT WAS RECOMMENDED THAT THE USER REBOOTS THE GENERATOR AND CONFIRMS A GOOD CONNECTION WITH THE GROUND PAD. IT WAS REPORTED THAT THE TROUBLESHOOTING STEPS REVIEWED DURING THE ORIGINAL CALL DID NOT RESOLVE THE ISSUE. NO IT WAS REPORTED THAT RESTARTING THE GENERATOR AND ENSURING THAT THE GROUNDING PAD WAS SECURED DID NOT RESOLVE THE ISSUE. IT WAS REPORTED THAT THE GENERATOR WAS RETURNED FOR ANALYSIS, BUT THE TRACKING NUMBER WAS UNKNOWN. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9721864 ↗
• MalfunctionFeb 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A RADIOFREQUENCY ABLATION (RFA) SYSTEM. IT WAS REPORTED THAT THERE WAS A F07 CODE DISPLAYED ON THE GENERATOR. IT WAS REPORTED THAT THE SYSTEM WAS SENT IN FOR ANALYSIS. IT WAS REPORTED THAT THE RMA #S FOR THE GENERATOR AND HUB ARE 2070035 AND 2070036 RESPECTIVELY. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE F07 ERROR OCCURRED DURING A LIVE PROCEDURE UPON PRESSING THE ENERGY DELIVERY BUTTON IN MOTOR MODE. THE SYSTEM SHOWED THE F07 ERROR IMMEDIATELY, AND NO ENERGY WAS DELIVERED. A SECOND RFA SYSTEM WAS USED WITH THE SAME RESULTS. THE PATIENT WAS TREATED WITH A COMPETITOR'S SYSTEM THAT THEY HAD ON HAND. IT WAS REPORTED THAT THE GENERATOR WAS SENT STRAIGHT TO RBC FOR ANALYSIS. THE FOLLOWING TRACKING NUMBERS WERE PROVIDED: (B)(4). NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720118 ↗
• InjurySep 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA THE HEALTHCARE PROFESSIONAL (HCP) REGARDING A RADIO FREQUENCY ABLATION (RFA) SYSTEM. THE REP IS IN THE MIDDLE OF A CASE AND THEY ARE GETTING CODE F07. THE GROUNDING PAD IS SECURELY IN THE LEFT FLANK AND HAS GOOD CONTACT. THE REP CONFIRMED THAT THEY FOLLOWED PROPER TROUBLESHOOTING GUIDANCE AND REBOOTED THE SYSTEM PRIOR TO CALLING TECHNICAL SERVICES. THEY ONLY GET THE F07 CODE WHEN THEY ACTIVATE MOTOR OR SENSORY TESTING. THE REP CONFIRMED THAT EVERY PROBE IS CONNECTED AND WITHIN TEMPERATURE. TECHNICAL SERVICES REVIEWED RETRIEVING A SECOND GROUNDING PAD TO SEE IF THAT RESOLVES THE CODE. THE MANAGING PHYSICIAN INDICATED THAT IT DID NOT RESOLVE THE CODE. THE HCP¿S MAJOR COMPLAINT IS THAT THERE IS NO WAY OF KNOWING THE SYSTEM IS GOING TO FALL UNTIL THEY ARE IN THE MIDDLE OF THE CASE AND THAT IS A RISK TO THE PATIENT. TECHNICAL SERVICES TRANSFERRED THE REP TO HAVE THE SYSTEM REPLACED. THE CALLER CONFIRMED THAT THE PATIENT IS GETTING TAKEN OUT OF THE OPERATING ROOM (OR) AND THEY PLAN TO RESCHEDULE THE PROCEDURE. THE SYMPTOMS REPORTED WERE PATIENT DISCOMFORT. THE RMA NUMBER IS (B)(4). NO FURTHER COMPLICATIONS WERE REPORTE

  Patient problems: Discomfort

  MAUDE report 9047725 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181864. One submission often covers many models, so check the product and lot details in each record.

• Z-2690-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically i
• Z-2695-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically
• Z-2693-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically
• Z-2692-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically
• Z-2694-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically i
• Z-2691-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically