NA RF-DGP-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05415067028921), received between Dec 17, 2018 and Mar 17, 2023 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Grounding Malfunction” (2 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SECOND AND THIRD-DEGREE GROUNDING PAD BURNS DURING AN RFA PROCEDURE ON (B)(6) 2023. SILVADENE WAS APPLIED TO THE AREAS WITH A DRESSING.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 16566858 ↗
• InjuryOct 30, 2022Grounding Malfunction; Adverse Event Without Identified Device or Use Problem; Grounding Malfunction; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GROUNDING PAD BURN. AN ANTIBIOTIC OINTMENT, GAUZE AND TEGADERM WERE USED FOR TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15697517 ↗
• InjuryOct 19, 2022Grounding Malfunction; Grounding Malfunction

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SECOND-DEGREE GROUNDING PAD BURN. THE PATIENT WAS INSTRUCTED TO APPLY ALOE AND LOTION TO THE BURN SITE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15636606 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2184149-2020-00126. DURING AN L2-L5 ABLATION PROCEDURE THE PATIENT SUSTAINED THIRD DEGREE BURNS. THE GROUNDING PAD HAD BEEN PLACED ON THE POSTERIOR RIGHT THIGH, ON HAIRY SKIN THAT HAD NOT BEEN PREPARED. DURING THE PROCEDURE NO ALARMS WERE EXPERIENCED, AND THE PROCEDURE WAS COMPLETED WITH NO PERFORMANCE ISSUES. UPON REMOVAL OF THE GROUNDING PAD THE PATIENT WAS NOTED TO HAVE A THIRD DEGREE BURN THAT WAS TREATED WITH SILVADENE. THE PATIENT HAS REMAINED IN STABLE CONDITION.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 10458949 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3002953813-2019-00071. DURING A RADIOFREQUENCY ABLATION PROCEDURE OF THE RIGHT MEDIAL BRANCH NERVES, A BURN OCCURRED AT THE GROUNDING PAD SITE. BEFORE THE PROCEDURE SKIN PREP WAS PERFORMED AND THE GROUNDING PAD WAS PLACED ON THE RIGHT POSTERIOR THIGH. WHEN THE GROUNDING PAD WAS REMOVED, A PARTIAL THICKNESS SKIN BURN WITH BLISTERING WAS NOTED. THE PATIENT WAS TREATED WITH SILVER SULFADIAZINE OINTMENT AND ANTIBIOTICS AND HAS REMAINED IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY DEVICE DURING THE PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9386510 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LEFT LUMBAR RADIOFREQUENCY ABLATION PROCEDURE A THIRD DEGREE BURN OCCURRED AT THE GROUNDING PAD SITE. WHEN THE PROCEDURE WAS COMPLETED AND THE GROUNDING PAD WAS DISCONNECTED FROM THE GENERATOR AND REMOVED, REDNESS AND BLISTERING WAS OBSERVED AT THE RIGHT LOWER LUMBAR REGION WHERE THE GROUNDING PAD HAD BEEN PLACED. THE GROUNDING PAD HAD NOT OVERLAPPED ANY OTHER PAD, THERE WERE NO WRINKLES OR LIFTED EDGES AS WELL. THE PATIENT WAS NOTED TO HAVE DRY SKIN. TAPE AND GAUZED WERE APPLIED TO THE BURN AND A TRIPLE ANTIBIOTIC OINTMENT WAS RECOMMENDED. ON (B)(6) 2019 THE CUSTOMER WAS INFORMED THE SECOND DEGREE BURN HAD PROGRESSED INTO A THIRD DEGREE BURN AND BURN OINTMENT WAS PRESCRIBED FOR TREATMENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 9310179 ↗
• InjuryOct 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  RELATED MANUFACTURER REFERENCE NUMBER: 2184149-2019-00198, 2182269-2019-00184, 2182269-2019-00185. DURING A CERVICAL SPINE ABLATION PROCEDURE, THE GROUNDING PAD WAS PLACED ON THE PATIENT'S RIGHT FLANK. WHILE ABLATION WAS BEING PERFORMED THE PATIENT COMPLAINED OF A BURNING SENSATION FROM THE GROUNDING PAD. THE PAD WAS REMOVED BUT NO BURN OR INFLAMMATION WAS NOTED. THE GROUNDING PAD WAS REPLACED WITH THE SAME LOT NUMBER AND PLACED ON THE PATIENT'S LEFT SIDE. THE SAME ISSUE OCCURRED WITH THE PATIENT HAVING A BURNING SENSATION. THE GROUNDING PAD WAS REPLACED AGAIN WITH THE SAME LOT NUMBER, AND THE ISSUE RECURRED. THE PROCEDURE ENDED UP BEING CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Burning Sensation

  MAUDE report 9238005 ↗
• InjuryOct 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  ADDITIONAL RELATED MANUFACTURER REFERENCE NUMBER: 2182269-2019-00241.

  Patient problems: Burning Sensation

  MAUDE report 9237990 ↗
• InjuryOct 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  RELATED MANUFACTURER REFERENCE NUMBER: 2184149-2019-00198, 2182269-2019-00185, 2182269-2019-00186. DURING A CERVICAL SPINE ABLATION PROCEDURE, THE GROUNDING PAD WAS PLACED ON THE PATIENT'S RIGHT FLANK. WHILE ABLATION WAS BEING PERFORMED THE PATIENT COMPLAINED OF A BURNING SENSATION FROM THE GROUNDING PAD. THE PAD WAS REMOVED BUT NO BURN OR INFLAMMATION WAS NOTED. THE GROUNDING PAD WAS REPLACED WITH THE SAME LOT NUMBER AND PLACED ON THE PATIENT'S LEFT SIDE. THE SAME ISSUE OCCURRED WITH THE PATIENT HAVING A BURNING SENSATION. THE GROUNDING PAD WAS REPLACED AGAIN WITH THE SAME LOT NUMBER, AND THE ISSUE RECURRED. THE PROCEDURE ENDED UP BEING CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Burning Sensation

  MAUDE report 9237989 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2184149-2019-00197. DURING A CERVICAL SPINE ABLATION PROCEDURE A PATIENT BURN OCCURRED. PRIOR TO THE PROCEDURE NO SKIN PREPARATION WAS PERFORMED AND THE GROUNDING PAD WAS PLACED ON THE LEFT SCAPULAR REGION, WHICH WAS HAIRY. AFTER RADIOFREQUENCY ABLATION HAD BEEN DELIVERED, A SUPERFICIAL BURN WITH BLISTERING WAS NOTED UNDER THE GROUNDING PAD. THE PAD WAS REMOVED BUT NO TREATMENT WAS REQUIRED. THE GROUNDING PAD WAS REPLACED AND THE PROCEDURE WAS CONTINUED WITH NO FURTHER ISSUES. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9237952 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3002953813-2019-00051. DURING A BILATERAL LUMBAR RADIOFREQUENCY ABLATION PROCEDURE, A PATIENT BURN OCCURRED. THE SKIN WAS PREPPED, AND THE GROUNDING PAD WAS PLACED ON A NON-HAIRY PART OF THE POSTERIOR THIGH. NO ALARMS WERE NOTED THROUGHOUT THE PROCEDURE BUT UPON REMOVAL OF THE GROUNDING PAD A SECOND-DEGREE BURN WAS NOTED. THE PATIENT WAS STARTED ON ANTIBIOTICS FOR TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 8875880 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2184149-2019-00118. DURING A LUMBAR RADIOFREQUENCY ABLATION PROCEDURE, A PATIENT BURN OCCURRED. THE SKIN WAS PREPPED, AND THE GROUNDING PAD WAS PLACED ON THE RIGHT LOWER SIDE ABOVE THE HIP BONE, MAKING FULL CONTACT. NO ALARMS WERE NOTED THROUGHOUT THE PROCEDURE BUT UPON REMOVAL OF THE GROUNDING PAD A BURN WAS NOTED WITH BLISTERING. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR FURTHER TREATMENT AND HAS REMAINED IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Burn(s)

  MAUDE report 8821155 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 2184149-2019-00047. DURING A L4-S1 RHIZOTOMY PROCEDURE, A PATIENT BURN OCCURRED. DURING THE PROCEDURE, THE GENERATOR DISPLAYED AN UNKNOWN ERROR MESSAGE THAT A GROUNDING PAD ISSUE OCCURRED. THE PAD WAS ADJUSTED AND THE LESION WAS STARTED AGAIN. TOWARDS THE END OF THE LAST LESION SITE, THE PATIENT EXPERIENCED PAIN. IT WAS DISCOVERED THAT THE PATIENT HAD A SECOND DEGREE BURN AT THE GROUNDING PAD SITE ON THE LEFT FLANK. THE PROCEDURE WAS ABANDONED. THE GROUNDING PAD DID NOT OVERLAP WITH ANY OTHER PATCHES. THERE WERE NO WRINKLES OR EDGES THAT WERE LIFTED. THE SKIN WAS NOT PREPPED AND PLACED ON TOP OF CLEAN DRY SKIN. THE BURN WAS CLEANED WITH ALOE VESTA SKIN CLEANSER AND SILVADENE CREAM 1% WAS APPLIED ON A STERILE PAD AND PLACED WITH MEDIPORE TAPE. THE PATIENT WAS STABLE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8505852 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 2184149-2018-00207. DURING AN ABLATION PROCEDURE, A PATIENT BURN OCCURRED. THE PATIENT EXPERIENCED A BURNING PAIN AT THE GROUNDING PAD LOCATION AND THE PROCEDURE WAS STOPPED. BLISTERS WERE NOTED AROUND THE PERIMETER OF THE GROUNDING PAD LOCATED ON THE LATERAL HIP. THERE WERE FOUR BLISTERS WITH VARYING SIZES. THE PAD WAS REMOVED AND A NEW GROUNDING PAD WAS PLACED ON THE OPPOSITE SIDE OF THE BODY ON THE SAME AREA. THE LESION WAS THEN ABLE TO BE COMPLETED WITH NO ADDITIONAL ISSUES. THE BURN WAS TREATED WITH TRIPLE ANTIBIOTIC OINTMENT WITH PADDED TEGADERM AND THE PATIENT IS BEING FOLLOWED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8170903 ↗