Valleylab E7510-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884524001043), received between Mar 6, 2018 and May 28, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Flare or Flash” (1 report).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO HOURS AFTER THE PROCEDURE, A LESS THAN 3CMX3CM THIRD DEGREE BURN WHEN VIEWED WITH THE NAKED EYES WAS DISCOVERED ON THE PATIENT'S BUTTOCK AREA. THE PAD WAS ATTACHED ACROSS THE BACK AND BUTTOCKS AS THE PATIENT WAS A CHILD. IT WAS INITIALLY SEVERE BUT GRADUALLY RECOVERING AS ALL AVAILABLE BEST TREATMENTS LIKE DRESSING FOR BURN INJURY WERE PROVIDED FOR 3 WEEKS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25320638 ↗
• MalfunctionJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BABY HAD A 2ND DEGREE BURN ON LEFT LATERAL THIGH. THE UNIT AND PATIENT PAD WAS USED ALONG WITH A NON-MEDTRONIC HANDPIECE. CONSULTED AND TREATED TO BURN CENTER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21120888 ↗
• MalfunctionAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, A BABY HAD THREE MINOR BURNS ON ABDOMEN. THE UNIT HAD TO BE CHECKED. IT WAS IDENTIFIED THAT THE BURN WAS NOT CAUSED BY THE UNIT, PLAQUE OR ELECTROCAUTERY. WHEN USING ELECTROCAUTERY, THE CUT DID NOT WORK. THE ELECTROCAUTERY WAS CHANGED THREE TIMES AND THE THIRD ONE FUNCTIONED. THE PATIENT IS NOW WELL AND LEFT THE HOSPITAL.

  Patient problems: Burn(s)

  MAUDE report 19921544 ↗
• MalfunctionMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL VENTRICULAR ATRIO CHANNEL CORRECTION PROCEDURE, THE DISPOSABLE PLATE WAS GLUED TO THE BACK (DORSAL REGION) OF THE PATIENT. HOWEVER, THE BURN WAS ON THE PATIENT'S LEG. AS SHOWN ON THE PHOTO REPORT, THE PATIENT RECEIVED 2ND DEGREE BURN, BULLOUS LESIONS ON THE LEFT LEG, ON THE SHIN, CHARACTERISTIC OF A BURN SHOWN SMALL BUBBLES. IT WAS UNKNOWN WHETHER THE REM PAD OR HANDPIECE CAUSED THE BURN ON THE LEG BECAUSE THE SURGERY IS CARDIAC, AND THE ACCESSORIES WERE USED ON THE CHEST AREA AND NOT ON THE LEG. THE CAUTERY PEN WAS ALSO VISIBLE IN THE PHOTO AS DAMAGED AND MELTED INSULATION. IT WAS CONFIRMED FROM THE FOLLOW-UP THAT THE CAUTERY PEN USED WAS NON-MEDTRONIC DEVICE. THE PATIENT WAS DISCHARGED NORMALLY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18908980 ↗
• MalfunctionJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AN INSPECTION WAS REQUESTED FOR POSSIBLE BURNS ALONG THE EDGE PART OF THE RETURN ELECTRODE. TWO WEEKS AFTER THE SURGERY, IT BECAME CLEAR THAT THE HAIR HAD FALLEN OUT AND BECAME LIKE A KELOID (FIRST DEGREE BURN) WHEN THE VISIT TO THE HOSPITAL WAS DONE FOR SUTURE REMOVAL. IT WAS NOTED THAT THE RETURN ELECTRODE SITE BECAME KELOID-LIKE (FIRST DEGREE BURN). THE KELOID WAS NOT CONFIRMED DURING AND IMMEDIATELY AFTER THE PROCEDURE DUE TO THE ANIMAL'S FUR. NO TREATMENT WAS PROVIDED. IT WAS NOTED DURING CONDITION CHECKING THAT THE PEDIATRIC RETURN ELECTRODE WAS REUSED AND A GEL WAS APPLIED ON THE ELECTRODE PART AND THE ALARM OF THE RETURN ELECTRODE CONTACT STATUS MONITORING SYSTEM DID NOT SOUND. CASE WAS USED ON VETERINARY CLINIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 17425642 ↗
• MalfunctionMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER ORCHIDOPEXY SURGERY, BURNS OCCURRED IN A 9 MONTHS OLD INFANT AFTER THE BABY RETURNED TO THE PATIENT ROOM. BASED ON HEAD OPERATING ROOM INFORMATION THE INSTALLATION OF REM POLYHESIVE WAS IN ACCORDANCE WITH THE FACTORY INSTRUCTIONS, AND THE INDICATOR IN UNIT FORCE FX SHOWS THAT THE REM POLYHESIVE HAS BEEN INSTALLED PROPERLY. BUT WHEN DURING OPERATING PROCEDURE THE PATIENT WAS USE WARM BLANKETS AND METAL PLATES PLACED BEHIND THE PATIENT BODY.

  Patient problems: Burn(s)

  MAUDE report 13664277 ↗
• MalfunctionFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TOE AMPUTATION PROCEDURE, THE PAD READ GREEN REM ON THE FORCETRIAD AND A BURN RESULTED ON THE CANINE PATIENT. THE PATIENT WAS THE FIRST SURGERY OF THE DAY AND WAS PLACED IN RIGHT LATERAL RECUMBENCY ON A TOWEL WHICH WAS ON TOP OF A HEATED WATER BLANKET. THE LEFT LATERAL ABDOMEN WAS CLIPPED AND THE VALLEY LAB REM POLYHESIVE INFANT PATIENT RETURN ELECTRODE, 6-30LB WAS PLACE ON THE SHAVED ABDOMEN AREA. THE PAD HAD PREVIOUSLY BEEN USED BUT THE DATE IS UNCERTAIN. NO REDUX GEL WAS USED ON THIS PATIENT. WHEN THE PAD WAS APPLIED, THE WHITE PAPER WAS REMOVED AND THE TECHNICIAN STATED IT WAS STICKY AND ADHERED TO THE PATIENT WELL AND THE REM TURNED GREEN. NO TAPE OR VETWRAP WAS APPLIED, JUST THE PAD. AS IN THE IMAGE, THERE MAY HAVE BEEN EVIDENCE OF REDUX GEL USED PREVIOUSLY BUT COULD NOT BE CONFIRMED. THE SETTINGS ON THE UNIT WERE 25 CUT, 30 V, 35 COAG. THE PROCEDURE WAS STARTED AND THE CAUTERY PEN USED FOR NEARLY THE WHOLE SURGERY WITHOUT INCIDENT UNTIL THE DOCTOR HEARD A SIZZLE SOUND. THE PEN DEVICE WAS INSPECTED AND WIRE TO THE UNIT WITH NO OBVIOUS ABNORMALITIES. THE PATIENT WAS UNDRAPED AND THE PAD WAS EXAMINED FROM THE TOP BUT NOT REMOVED TO LOOK UNDER

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13589367 ↗
• MalfunctionDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ATRIAL SEPTAL DEFECT REPAIR ON THE HEART, THEY NOTICED THAT THE PATIENT PAD SIGHT (RIGHT THIGH) WAS BURN UPON COMPLETION OF THE CASE. THE CUSTOMER DIDN'T SPECIFY THE SIZE OF BURN AND HOW IT WAS TREATED. THE DEGREE OF BURN WAS ALSO ASKED BUT NOT ANSWERED. THEY DIDN'T NOTICE ANYTHING WRONG WITH THE REM PAD PRIOR TO APPLYING IT FOR THE CASE.

  Patient problems: Burn(s)

  MAUDE report 13115130 ↗
• MalfunctionJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE MASTOIDECTOMY PROCEDURE ON THE RIGHT SIDED NECK MASS EXCESSION, THERE WAS A 5MM FIRST DEGREE BURN ON THE FACE OF THE PATIENT CLOSE TO THE OPERATION SITE, DISCOVERED BY THE THEATRE NURSE AT THE END OF THE SURGERY. THERE WAS PATIENT'S NON SERIOUS INJURY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 12229774 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON INGUINAL HERNIA SURGERY, THE DEVICE BURNT THE PATIENT'S BODY. THE NEW PAD WAS APPLIED TO CLEAN DRY SKIN BUT THE BACK SIDE OF THE PATIENT WAS WET BECAUSE OF CREAM. THE PATIENT WAS IN PEDIATRIC INTENSIVE CARE UNIT DUE TO LOW BODY TEMPERATURE AND FOUND THE BURN FOUR HOURS LATER. PHOTOGRAPH WAS RECEIVED AND SHOWED THE PATIENT'S BUTTOCKS WAS BURN WITH BLISTERS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 11797877 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A HIGH LIGATION OF THE RIGHT PERITONEAL SHEATH PROCEDURE, THE PATIENT SUFFERED ECTOPIC BURNS. IT WAS NOTED THAT THERE WAS TISSUE DAMAGE DUE TO BURNS FROM THE ROOTS OF THE LEGS TO THE LOWER ABDOMEN.

  Patient problems: Burn(s); Tissue Damage

  MAUDE report 10745745 ↗
• MalfunctionOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST SURGERY OF HEART DEFECT REPAIR, THERE WERE BURN MARKS NOTED ON PATIENT'S SKIN FROM RETURN PAD PLACEMENT WHICH WAS DIAGNOSED AS FIRST DEGREE BURN. IT WAS A SIZE OF (B)(6). BURN LOCATION ON THE SCAPULA OF THE PATIENT AND TREATED BY USING TOPICAL CREAMS.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 7967244 ↗
• MalfunctionMar 6, 2018Flare or Flash; Flare or Flash

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS A BURN AT THE PAD SITE WHEN USING THE DEVICE. THE BURN DISCOVERED AFTER THE PROCEDURE AND WAS SIZE AS THE PAD. AS REPORTED, THE PATIENT ACQUIRED A TEMPORARY INJURY.

  Patient problems: Burn(s)

  MAUDE report 7318063 ↗