Valleylab E7507Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 10884524000077), received between Oct 24, 2016 and Aug 28, 2026 — classified as 27 injuries, 165 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 192 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Material Discolored; Device Damaged Prior to Receipt by User; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493831 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING CLAVICLE RAFI (OPEN REDUCTION AND INTERNAL FIXATION), THE PATIENT HAD A 3RD DEGREE BURN ON THE LEFT SIDE OF THE BACK COINCIDING WITH THE CLAVICLE PROCEDURE SIDE. THE ELECTROCAUTERY PLATE WAS PLACED ON THE RIGHT ARM, WITHOUT ANY PROBLEMS SENSING. THE BURN WAS TREATED WITH PLASTIC SURGERY. THE PATIENT REMAINS ADMITTED AT THE TIME OF THIS REPORT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25300785 ↗
• MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A MINIMALLY INVASIVE CARDIAC SURGERY FOR MITRAL VALVE REPAIR, A PATIENT WAS BURNED ON HIS GENITAL AREA (PENIS) WITH VISIBLE BLISTERS. THE STAFF NOTICED THE BLISTERS ONCE THE CASE WAS COMPLETED AS IT WAS COVERED DURING THE PROCEDURE. THE PATIENT PLATE WAS PLACED ON THE BUTTOCK. ALCOHOL WAS WIPED AWAY FROM THE SITE WHERE THE PLATE WAS USED. THE PROCEDURE SETTINGS WERE 15 COAG AND 15 CUTTING. THE SURGEON WAS USING A COVIDIEN EDGE BUTTON SWITCH PENCIL SO HE WAS CHANGING THE ENERGY AS NEEDED FROM THE PENCIL.

  Patient problems: Burn(s)

  MAUDE report 24933621 ↗
• MalfunctionApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT HAD FIRST DEGREE SKIN BURN AT THE THIGH WERE THE REM PAD WAS PLACED. NO TREATMENT WAS DONE TO THE BURN SITE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24872305 ↗
• InjuryApr 6, 2026Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE INVOLVING THE DEVICE, THE DEVICE WAS NOT RECOGNIZED BY THE EQUIPMENT. THE PROCEDURE WAS ABORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793786 ↗
• MalfunctionMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT HAD A FIRST DEGREE BURN ABOUT A SIZE OF A QUARTER ON THE UPPER LEG. THE REM (RETURN ELECTRODE MONITORING) PAD WAS REPLACED, AND THE SAME BOVIE AND GENERATOR WERE USED WITH NO ISSUES. THIS DID NOT CAUSE AN EXTENDED HOSPITAL STAY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24648498 ↗
• MalfunctionMar 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 24579146 ↗
• MalfunctionMar 9, 2026Contamination; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT HAD BURN. PHOTO OBSERVATION SHOWED THE ACRYLIC ADHESIVE STRIP IS WITH MOISTURE WHEN OPENED WITH THE WHITE COVER PAPER.

  Patient problems: Burn(s)

  MAUDE report 24552153 ↗
• MalfunctionMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A REVISION PALMER TOTAL KNEE PROCEDURE, A PATIENT SUSTAINED A VERY SMALL FIRST-DEGREE BURN CHARACTERIZED BY REDNESS ON THE UPPER LEG, APPROXIMATELY QUARTER SIZED. THE PATIENT DID NOT EXTEND HOSPITAL STAY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24551867 ↗
• MalfunctionMar 9, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BURN.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 24551802 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, THE CAUTERY WAS NOT ACTIVATING AND WAS MISFIRING AT THE START OF THE CASE. ALL CONNECTIONS WERE CHECKED BY THE CIRCULATOR AND SCRUB NURSE. THE SURGEON WAS ADVISED TO CHECK THE CAUTERY TIP CONNECTION, AND IN RESPONSE, REMOVED AND REINSERTED THE TIP. THE PATIENT UNDERWENT SURGERY, AND ONCE THE DAVIS-BOYLE GAG WAS RELEASED, THE SURGEON IDENTIFIED SIGNIFICANT PARTIAL TO FULL-THICKNESS BURNS TO THE BILATERAL CORNERS OF THE PATIENT¿S MOUTH THAT HAD OCCURRED DURING THE PROCEDURE. THE SURGEON IMMEDIATELY APPLIED SALINE-SOAKED GAUZE TO THE AREA. PLASTIC SURGERY WAS NOTIFIED, AND A STAFF CAME TO THE ROOM TO EXAMINE THE AREA AND WILL FOLLOW THE PATIENT. THE PLASTIC SURGERY TEAM COMPLETED AN ASSESSMENT, TOOK PHOTOGRAPHS, AND RECOMMENDED ADMISSION OF THE PATIENT. THE SITE WAS CLEANSED WITH STERILE NS, DRIED, AND POLYPORE OINTMENT WAS APPLIED TO THE AFFECTED AREAS BY THE ENT SURGEON. THE PATIENT REQUIRED ADDITIONAL ANESTHESIA TIME.

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

  MAUDE report 24413729 ↗
• MalfunctionJan 22, 2026

  GROUNDING PADS WITH SPOTS THAT APPEAR MOLDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144046 ↗
• MalfunctionJan 16, 2026

  DARK CIRCLES ON UNUSED ADHESIVE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092959 ↗
• MalfunctionDec 30, 2025Microbial Contamination of Device

  WHEN OPENING A GROUNDING PAD TO USE FOR A PROCEDURE THE GROUNDING PAD APPEARED SPOTTED? MOLD OR OTHER CONTAMINANT TO THE PAD. SUPPLY STAFF WERE INSTRUCTED TO REMOVE THIS LOT NUMBER FROM CIRCULATION IN OUR PROCEDURE ROOMS AS MULTIPLE PRODUCTS APPEAR AFFECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921599 ↗
• MalfunctionDec 26, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MERGE TO PE #707585239: IT WAS REPORTED THAT DURING THE ROBOTIC HYSTERECTOMY, THE PATIENT GOT A FIRST DEGREE BURN UNDER THE BOVIE PAD.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23895036 ↗
• MalfunctionDec 2, 2025Difficult to Remove; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PADS WERE VERY STICKY, CAUSING REACTIONS AND TEARING THE SKIN. WHEN IT WAS REMOVED IT ALMOST CAUSED A BRUISE.

  Patient problems: Local Reaction; Skin Tears

  MAUDE report 23692750 ↗
• MalfunctionDec 2, 2025Difficult to Remove; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE PADS WERE VERY STICKY, CAUSING REACTIONS AND TEARING THE SKIN. WHEN IT WAS REMOVED IT ALMOST CAUSED A BRUISE.

  Patient problems: Local Reaction; Skin Tears

  MAUDE report 23691469 ↗
• MalfunctionNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TOTAL KNEE REPLACEMENT ON THE LEFT KNEE, UPON REMOVING REM PAD FROM PATIENT, STAFF NOTICED THERE WAS PURPLISH DISCOLORATION ON PATIENTS SKIN OUTLINING THE PERIMETER OF THE PAD WITH REDNESS WITHIN THE PERIMETER. STAFF WAS CONCERNED PATIENT MAY HAVE BEEN BURNED FROM THE REM PAD. STAFF ALSO COMMENTED THAT PHYSICIAN HAD SETTINGS ON 90 CUT 90 COAG ON MONOPOLAR SETTING WHILE WORKING ON BONE.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 23591633 ↗
• MalfunctionNov 11, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD.

  Patient problems: Burn(s); Peeling

  MAUDE report 23524019 ↗
• MalfunctionNov 5, 2025Material Discolored; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Material Discolored; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD. THERE WAS A BLACK CIRCULAR SPOT FOUND IN ONE OF THE PAD AS SHOWN IN THE PICTURES PROVIDED.

  Patient problems: Burn(s); Peeling

  MAUDE report 23474024 ↗
• MalfunctionNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BILATERAL HIP REPLACEMENT PROCEDURE, A BURN WAS IDENTIFIED AND WAS TREATED BY APPLYING SILVER SULFADIAZINE CREAM AT BEDSIDE. THE PAD WAS PLACED ON THE LEFT THIGH. PHOTO RECEIVED SHOWED THAT THE BURN WAS LOCATED IN THE PATIENT'S THIGH AND IS ALMOST AN OUTLINE OF A PAD. THE GENERATOR WAS USED ALONG WITH A PAD THAT CONTAINED THE SAME LOT NUMBER AND THERE WERE NO ISSUES.

  Patient problems: Burn(s)

  MAUDE report 23465028 ↗
• MalfunctionNov 4, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD. THERE WAS A BLACK CIRCULAR SPOT FOUND IN ONE OF THE PADS AS SHOWN IN THE PICTURES PROVIDED.

  Patient problems: Burn(s); Insufficient Information; Peeling

  MAUDE report 23464787 ↗
• MalfunctionNov 4, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD. THERE WAS A BLACK CIRCULAR SPOT FOUND IN ONE OF THE PAD AS SHOWN IN THE PICTURES PROVIDED.

  Patient problems: Burn(s); Insufficient Information; Peeling

  MAUDE report 23464611 ↗
• MalfunctionNov 4, 2025Material Discolored; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Discolored; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD.

  Patient problems: Burn(s); Insufficient Information; Peeling

  MAUDE report 23464213 ↗
• MalfunctionNov 4, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD.

  Patient problems: Burn(s); Insufficient Information; Peeling

  MAUDE report 23464121 ↗