ThermoGard CRA-SGPRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20653405986581), received between Jul 9, 2020 and Aug 19, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K140658); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Insufficient Device Problem Information

  The customer reported that a CRA-SGP, THERMOGARD DUAL DISPERSIVE ELECTRODE,CONTACT QUALITY MONITOR, device was used during a cervical coolief procedure on an unknown date when it was reported, ¿Patient sustained a burn beneath the grounding pad. They state the grounding pad started on the left lateral thigh of the patient, but they noticed that the grounding pad slid out of position, so they removed it and wiped the skin dry then placed in the original position. Once the procedure was finished, they noticed slight redness/warmth on the skin where the grounding pad was placed. She reports that they checked the skin again after they removed him from the room and noticed that there was some peeling up of the skin with discoloration where the pad was placed.¿ The patient is reported as ¿ok." When asked if there was medical intervention the reporter stated, ¿treated and dressed." There was no report of hospitalization for the patient.This report is being raised due to the reported injury of unknown degree of burn.

  Patient problems: Burn(s)

  MAUDE report 50320224 ↗
• InjuryDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE CRA-SGP, AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, DUAL FOIL DEVICE WAS USED IN A PROCEDURE ON APPROXIMATELY (B)(6) 2023, WHEN THE ¿GROUNDING PAD BECAME LOOSE AND LEFT A BURN ON THE CUSTOMER¿S CALF WHERE THE PAD WAS PLACED.¿. ADDITIONAL INFORMATION INDICATED THAT ¿PATIENT WAS SEEN FOR A COOLIEF RFTC OF THE GENICULATE NERVES. PATIENT RETURNED TO THE CLINIC, SAME DAY, WITH COMPLAINTS OF A BURN TO HER CALF WHERE THE GROUNDING PAD WAS PLACED.... GROUNDING PAD WAS NOT VISIBLE DURING THE PROCEDURE. AT THE END OF THE PROCEDURE WHEN THE TECHNICIAN WENT TO REMOVE THE PAD IT WAS NOTED TO BE LOOSE.... CALF PLACED HORIZONTALLY¿. ER VISIT, BURN TREATED WITH SILVADENE. FOLLOW UP WITH PLASTIC SURGERY.¿. A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A BURN OF UNKNOWN DEGREE TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 18411116 ↗
• InjuryFeb 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE CRA-SGP, AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿PATIENT RECEIVED A GROUNDING PAD BURN. WHEN STAFF TOOK PAD OFF, THEY NOTICED THREE LITTLE STRIPS OF REDNESS ON R FLANK AREA. SKIN WAS CHECKED BEFORE PLACEMENT. REP SAID THE USUAL PERSON WHO RUNS THE GENERATOR WAS NOT IN THE PROCEDURE AND THAT THE PERSON WHO WAS THERE TODAY WAS NEW. STATES THE PERSON HAD TO BE TALKED THROUGH BUT THE PROCEDURE WENT WELL AND WITHOUT INCIDENT.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DELAY. FURTHER ASSESSMENT WAS UNABLE TO DETERMINE THE DEGREE OF BURN OR IF A BURN WAS DIAGNOSED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO POSSIBLE BURN TO PATIENT WITHOUT DEGREE OF BURN IDENTIFIED.

  Patient problems: Burn(s)

  MAUDE report 16435444 ↗
• InjuryAug 9, 2022Expiration Date Error; Device Dislodged or Dislocated; Expiration Date Error; Device Dislodged or Dislocated

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE CRA-SGP, AVANOS, DISPERSIVE ELECTRODE, WAS BEING USED DURING A LEFT L4, 5, SA FACET RADIO FREQUENCY ABLATION PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿PATIENT RESULTED IN 2ND DEGREE BURN ON LEG FROM GROUNDING PAD. PATIENT MENTIONED PAIN DURING PROCEDURE THAT SOUNDED SIMILAR TO USUAL COMPLAINTS, PRESENTED TO CLINIC TODAY (3-4 DAYS LATER) WITH BURN.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. FURTHER INFORMATION RECEIVED FOUND THAT THE EXPIRATION DATE HAD EXPIRED, AND THE DEVICE HAD BEEN USED WITHOUT CHECKING THE EXPIRATION DATE. AND WHEN THE EQUIPMENT WASN¿T GETTING THE RIGHT IMPEDANCE AND TEMPERATURE, THE CLINICIANS DECIDED TO SWITCH TO A DIFFERENT GENERATOR AND WENT TO REMOVE THE PAD AND IT SLID OFF THE LEG AS IF IT HAD NOT ENTIRELY ADHERED. THE PATIENT HAD A RELATIVELY HAIRY LEG AND WAS PERSPIRING SLIGHTLY BUT NOTHING OUT OF THE ORDINARY PER THE CLINICIANS. THE CLINICIANS DID NOT ASSESS THE LEG BETWEEN SWITCHING GENERATORS AS THE PATIENT WAS COVERED BY A STERILE DRAPE. THE PAIN GENERATOR IMPEDANCE WAS AROUND 1000 AND THE TEMPERATURE WOULD NOT GO ABOVE 40 DEGREES. THE BURN WAS A

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15192555 ↗
• MalfunctionAug 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT THE DEVICE, CRA-SGP, AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, DUAL FOIL, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿WE HAVE BEEN HAVING CONTINUING ISSUES WITH OUR RF GROUNDING PADS, WHEN WE PUT THEM ON THE PATIENT AN ALERT COMES UP SAYING POOR SKIN CONTACT OR GROUNDING PAD NOT CONNECTED. WE ALWAYS MAKE SURE THIS PATIENT'S SKIN IS DRY, NOT OILY, OR HAIRY. WE END UP HAVING TO UNPLUG THEN REPLUG THE GROUNDING PAD BACK IN, SOMETIMES MULTIPLE TIMES. WE HAVE NOT HAD ANY PATIENT INJURY. WE HAVE THREE PADS ATTEMPTED TO THE USE ON ONE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15181916 ↗
• InjuryJun 22, 2022Overheating of Device; Overheating of Device

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE CRA-SGP, AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, WAS BEING USED DURING A RADIO FREQUENCY ABLATION - LUMBAR WITH VALIUM PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿GROUNDING PAD CAUSED 2 SMALL BURNS (SMALLER THAN A DIME) ON PATIENT'S LEFT LEG. BURNS PAINFUL PER PATIENT. DEFECTIVE GROUNDING PAD IMMEDIATELY REMOVED FROM POSTERIOR LEFT LEG AND NEW GROUNDING PAD APPLIED TO RIGHT LEG. PATIENT INFORMED OF INCIDENT AND PROVIDED TEACHING OF CARE OF SITE. ANTIBIOTIC OINTMENT PRESCRIBED BY MD. PADS WERE PLACED IN VERTICAL PLACEMENT ON THE LEFT CALF THE CORD CONNECTION TOWARD THE PATIENT¿S HEAD. NO ERROR MESSAGES, BUT AS SOON AS THE MACHINE AS TURNED ON THE PATIENT COMPLAINED OF PAIN IN HER LEFT LEG.¿ THE REPORTER STATED THAT ANTIBIOTIC OINTMENT WAS PRESCRIBED BY THE DOCTOR. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEGREE OF THE BURN IS UNKNOWN. THE CURRENT STATUS OF THE PATIENT IS LISTED AS ¿OUTPATIENT ¿ ALIVE¿. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION. WITH THE USE OF AN ALTERNATE DEVICE THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT SUSTAINING AN

  Patient problems: Burn(s)

  MAUDE report 14771743 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT INJURY WAS REPORTED DURING USE OF THE GROUNDING PAD, 2 (TWO) SMALL BURNS (SMALLER THAN A DIME) WERE PRESENT ON THE PATIENT'S LOWER LEFT EXTREMITY (LLE). THE BURNS WERE REPORTEDLY PAINFUL PER THE PATIENT. THE GROUNDING PAD WAS VERTICALLY PLACED ON THE LEFT CALF WITH THE CORD CONNECTION TOWARDS THE PATIENT¿S HEAD. THERE WERE REPORTEDLY NO ERROR MESSAGES; HOWEVER, AS SOON AS THE MACHINE WAS TURNED ON THE PATIENT COMPLAINED OF PAIN IN THEIR LEFT LEG. THE DEFECTIVE GROUNDING PAD WAS IMMEDIATELY REMOVED FROM THE POSTERIOR LLE AND A NEW GROUNDING PAD APPLIED TO THE RIGHT LOWER EXTREMITY (RLE). ANTIBIOTIC OINTMENT WAS PRESCRIBED BY THE PHYSICIAN, THE OUTPATIENT WAS PROVIDED INSTRUCTIONS FOR THE CARE OF THE SITE. IT WAS ADDITIONALLY NOTED THAT THE PATIENT WAS ALIVE.

  Patient problems: Burn(s); Pain

  MAUDE report 14706466 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED A "THIRD DEGREE BURN AT THE SITE OF WHERE THE GROUNDING PAD HAD BEEN DURING THE PROCEDURE." THE PATIENT WAS GIVEN SILVADENE CREAM AND REFERRED TO THE WOUND CARE TEAM FOR FURTHER MANAGEMENT. THE PATIENT HAD A GENICULAR RADIO FREQUENCY ABLATION (RFA) AND RETURNED AFTER THE WEEKEND WITH "THIRD DEGREE BURN" AT THE SITE OF WHERE THE GROUNDING PAD HAD BEEN DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 25-AUG-2020 STATED THE PROCEDURE WAS A RIGHT KNEE. THE EXACT LOCATION AND ORIENTATION OF THE GROUNDING PAD DURING THE PROCEDURE WAS VERTICALLY ON THE RIGHT CALF. DURING THE PROCEDURE THERE WERE GROUNDING PAD ADHERENCE ISSUES DURING THE PROCEDURE AND IT WAS ADDRESSED MIDWAY THROUGH. THE MACHINE SHUT OFF WITH WHAT WAS BELIEVED TO BE HIGH IMPEDANCE ERROR, BUT EXACT ERROR MESSAGE WAS NOT KNOWN. AT THAT POINT THE GROUNDING PAD WAS ASSESSED, AND ADHERENCE CORRECTED. THE PATIENT DID NOT HAVE ANY IMPLANTED HARDWARE DEVICES BUT THERE WERE DEFINITELY ADHERENCE ISSUES. THE DEFAULT SETTINGS ON THE RF PAIN GENERATOR WERE 60 AND 2:30. THE GROUNDING PAD PLACEMENT SITE WAS NOT INSPECTED AFTER THE PROCEDURE BUT NOTHING OBVIOUS WAS NOTED WHEN THE GROUNDING PAD WA

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 10556443 ↗
• InjuryJul 9, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE "CUSTOMER HAD DIFFICULTY WITH HIGH IMPEDANCE WARNINGS ON THE SECOND ABLATION DURING A LUMBAR CASE. THEY REPOSITIONED THE PROBE AND ADDED MORE LIDOCAINE AND TRIED MULTIPLE TIMES TO ABLATE BUT EVENTUALLY ABORTED THE CASE. IT WAS THEN DISCOVERED THAT THE PT [PATIENT] HAD A BURN UNDER THE GROUNDING PAD ON THE THIGH, DESCRIBED AS BLISTERS." SILVADENE WAS PRESCRIBED.

  Patient problems: Burn(s)

  MAUDE report 10254789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140658. One submission often covers many models, so check the product and lot details in each record.

• Z-2596-2016 · May 18, 2016 · Terminated
  Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical gene
• Z-2599-2016 · May 18, 2016 · Terminated
  Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 75
• Z-2597-2016 · May 18, 2016 · Terminated
  Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electr
• Z-2598-2016 · May 18, 2016 · Terminated
  Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 AB
• Z-2595-2016 · May 18, 2016 · Terminated
  Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurg