Valleylab E7509Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 30884524001009), received between Mar 14, 2017 and Jun 23, 2026 — classified as 6 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Contamination; Device Damaged Prior to Receipt by User; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO USE, UPON OPENING THE PACKAGE OF THE DEVICE, THE PRODUCT HAD NO ADHESIVE. THE PAD CONTAINED WHITE FOREIGN MATERIALS AS SHOWN IN THE PHOTO PROVIDED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THERE NO GEL NOTED ON THE FOIL OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591856 ↗
• MalfunctionFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SMALL BLISTER AT THE SITE WHERE THE PAD WAS APPLIED. NO TREATMENT WAS DONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24319603 ↗
• MalfunctionAug 26, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVELY, THE REM (RETURN ELECTRODE MONITORING) PAD HAD CAUSED PUSTULES AND SKIN LOOSENING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction

  MAUDE report 22892551 ↗
• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 TO 4 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED A SUN BURN LIKE WOUND ON SKIN AT BODY AREAS TOUCHING THE OPERATION BED. THE PATIENT HAD REDNESS ON THE BACK AND BUTTOCKS AREA, CLASSIFIED AS A FIRST-DEGREE BURN.

  Patient problems: Erythema; Superficial (First Degree) Burn

  MAUDE report 22792072 ↗
• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 TO 4 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED A SUN BURN LIKE WOUND ON SKIN AT BODY AREAS TOUCHING OPERATION BED. THE PATIENT HAD REDNESS ON THE BACK AREA, CLASSIFIED AS A FIRST-DEGREE BURN.

  Patient problems: Erythema; Superficial (First Degree) Burn

  MAUDE report 22791943 ↗
• MalfunctionJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 TO 4 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED A SUN BURN LIKE WOUND ON SKIN AT BODY AREAS TOUCHING OPERATION BED. BASED ON THE PHOTOS RECEIVED, THE PATIENT HAD REDNESS AND BLISTERING ON THE BACK AND BUTTOCKS AREA, CLASSIFIED AS A SECOND-DEGREE BURN.

  Patient problems: Blister; Burn(s); Erythema; Partial thickness (Second Degree) Burn

  MAUDE report 22468491 ↗
• MalfunctionDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SIX HOURS AFTER THE APPENDECTOMY PROCEDURE UNDER CEP ANESTHESIA, THE PATIENT REPORTED PAIN IN THE CALF. THE NURSE CHECKED AND FOUND THAT THE CALF HAD A BURN RANGE OF 1.5 CM BY 1.5 CM. THE RELEVANT MEDICAL STAFF AND NURSING STAFF WERE PROMPTLY ORGANIZED TO FIND OUT THE CAUSE OF THE EVENT AND COMFORTED THE PATIENT. THE NURSE DID SKIN CARE AND DRESSING CHANGES AND PREVENTED OCCURRENCE OF INFECTION. DURING THE OPERATION AN ELECTROSURGICAL GENERATOR WAS USED TO SEPARATE AND COAGULATE BODY TISSUES, THEREBY ACHIEVING THE PURPOSE OF CUTTING AND HEMOSTASIS. THE NEGATIVE PLATE OF THE ELECTROSURGICAL GENERATOR WAS CLOSE TO THE PATIENT'S CALF MUSCLES.

  Patient problems: Burn(s); Pain

  MAUDE report 20857172 ↗
• MalfunctionOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PATIENT HAD BURN IN BUTTOCKS AFTER SURGICAL PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 20397045 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LLETZ (LARGE LOOP EXCISION OF THE TRANSFORMATION ZONE) PROCEDURE AFTER UNDERGONE A HYSTEROSCOPY, THE PATIENT SUFFERED SECOND DEGREE BILATERAL BURNS TO THE BUTTOCKS AND VAGINAL BURNS. BURNS WERE NOT AT EITHER REM PAD OR SURGICAL SITE. A NON MEDTRONIC LOOP DIATHERMY WAS USED ALONG WITH THE REM PAD AND GENERATOR. DIRECT IRRIGATION AND DRESSING WERE DONE AFTER PROCEDURE AND THE PATIENT WAS ADMITTED TWO NIGHTS IN THE HOSPITAL.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18357364 ↗
• MalfunctionApr 21, 2022Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING SPINAL FUSION PROCEDURE, AN ELECTROSURGICAL UNIT (ESU) PAD WAS PLACED ON THE RIGHT POSTERIOR CALF AND LEFT POSTERIOR THIGH. NEUROMONITORING NEEDLE ELECTRODES WERE PLACED BILATERALLY ON PATIENT'S SHINS. THE LEFT POSTERIOR THIGH PAD WAS ALSO NOT ADHERING TO SKIN, SO A NEW PAD WAS PLACED ON THE LEFT POSTERIOR CALF. THE VENDOR NOTED THAT THERE WAS INTERFERENCE IN THE NEUROMONITORING FEEDBACK. A NEW PAD WAS PLACED AND RELOCATED TO UPPER RIGHT ARM. AT CASE CONCLUSION, THERE WERE BURNS NOTED AT MULTIPLE ELECTRODE SITES ON BILATERAL LOWER EXTREMITIES.

  Patient problems: Insufficient Information

  MAUDE report 14169668 ↗
• MalfunctionApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING SPINAL FUSION PROCEDURE, AN ELECTROSURGICAL UNIT (ESU) PAD WAS PLACED ON THE RIGHT POSTERIOR CALF AND LEFT POSTERIOR THIGH. NEUROMONITORING NEEDLE ELECTRODES WERE PLACED BILATERALLY ON PATIENT'S SHINS. THE LEFT POSTERIOR THIGH PAD WAS ALSO NOT ADHERING TO SKIN, SO A NEW PAD WAS PLACED ON THE LEFT POSTERIOR CALF. THE VENDOR NOTED THAT THERE WAS INTERFERENCE IN THE NEUROMONITORING FEEDBACK. A NEW PAD WAS PLACED AND RELOCATED TO UPPER RIGHT ARM. AT CASE CONCLUSION, THERE WERE BURNS NOTED AT MULTIPLE ELECTRODE SITES ON BILATERAL LOWER EXTREMITIES.

  Patient problems: Insufficient Information

  MAUDE report 14169449 ↗
• MalfunctionApr 21, 2022Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  ACCORDING TO THE REPORTER, DURING SPINAL FUSION PROCEDURE, AN ELECTROSURGICAL UNIT (ESU) PAD WAS PLACED ON THE RIGHT POSTERIOR CALF AND LEFT POSTERIOR THIGH. NEUROMONITORING NEEDLE ELECTRODES WERE PLACED BILATERALLY ON PATIENT'S SHINS. THE LEFT POSTERIOR THIGH PAD WAS ALSO NOT ADHERING TO SKIN, SO A NEW PAD WAS PLACED ON THE LEFT POSTERIOR CALF. THE VENDOR NOTED THAT THERE WAS INTERFERENCE IN THE NEUROMONITORING FEEDBACK. A NEW PAD WAS PLACED AND RELOCATED TO UPPER RIGHT ARM. AT CASE CONCLUSION, THERE WERE BURNS NOTED AT MULTIPLE ELECTRODE SITES ON BILATERAL LOWER EXTREMITIES.

  Patient problems: Insufficient Information

  MAUDE report 14169447 ↗
• MalfunctionFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE NURSE REMOVED THE RETURN ELECTRODE AT THE END OF PROCEDURE SHE NOTICED THAT THE PATIENT WAS BURNED AROUND THE PERIPHERAL EDGING OF PAD SURFACE ON SKIN.

  Patient problems: Burn(s)

  MAUDE report 13539086 ↗
• MalfunctionJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DARK PURPLE DISCOLORATION NOTED ON SKIN WHERE CAUTERY PAD SITE WAS (INNER THIGH) SHAPED LIKE CAUTERY PAD, WITH SMALL SKIN TEAR NOTED AS WELL WITH SCANT AMOUNT OF BLOOD.

  Patient problems: Burn(s)

  MAUDE report 13307160 ↗
• MalfunctionSep 23, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER 3 HOURS OF OPERATION, PURE CUT, ELECTRIC BURN OUTPUT MODE, 60W POWER SETTING, NEGATIVE PLATE NICKEL IRON IN THE THIGH INTERNAL TEST, SURGICAL SIDE SLEEPER, BETWEEN THE TWO THIGHS KNEE JOINT WITH PILLOW PAD SEPARATE, BETWEEN THE THIGHS SEPARATED BY A GAP. AFTER SURGERY, THE NEGATIVE PLATE REMOVED THE SKIN EDGE AS PINK, ONE HOUR LATER TURNED PURPLE, THE PATIENT IS NOW LIVING IN THE ORTHOPAEDIC WARD, THERE IS A WOUND PROFESSIONAL GROUP TO GIVE TREATMENT

  Patient problems: Skin Discoloration

  MAUDE report 12523897 ↗
• MalfunctionJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE PAD CAUSED BURN. THE BURN WAS TREATED WHILE THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND IT WAS DISCHARGED FROM THE HOSPITAL WHEN THE BURN WAS HEALED. IT WAS THE DAY AFTER THE SURGERY WHEN THE PATIENT¿S MOTHER NOTICED THE BURN AND REPORTED TO THE HOSPITAL. THE GENERATOR WAS CHECKED BY THE BIOMEDICAL TECHNICIAN AND FOUND WORKING PROPERLY.

  Patient problems: Burn(s)

  MAUDE report 12092876 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION COULD NOT BE CLEARLY PROVIDED ON THE DEGREE OF THE BURN OR TREATMENT PROVIDED. PICTURES WERE PROVIDED AND ONE OF THE PICTURES SHOWED WHAT APPEAR TO BE A 3RD DEGREE BURN, HOWEVER THE PATIENT IN THE PICTURE IS UNKNOWN. THIS EVENT IS BEING CONSERVATIVELY CONSIDERED TO HAVE INVOLVED A 3RD DEGREE BURN AND HAS BEEN EVALUATED AS A SERIOUS INJURY.

  Patient problems: Full thickness (Third Degree) Burn; No Code Available

  MAUDE report 9263864 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION COULD NOT BE CLEARLY PROVIDED ON THE DEGREE OF THE BURN OR TREATMENT PROVIDED. PICTURES WERE PROVIDED AND ONE OF THE PICTURES SHOWED WHAT APPEAR TO BE A 3RD DEGREE BURN, HOWEVER THE PATIENT IN THE PICTURE IS UNKNOWN. THIS EVENT IS BEING CONSERVATIVELY CONSIDERED TO HAVE INVOLVED A 3RD DEGREE BURN AND HAS BEEN EVALUATED AS A SERIOUS INJURY.

  Patient problems: Full thickness (Third Degree) Burn; Hyperemia; No Code Available

  MAUDE report 9263837 ↗
• InjuryOct 31, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, USING THE RETURN ELECTRODE MONITORING(REM) PAD THE PATIENT HAD SKIN LESION AND HYPEREMIA. INFORMATION PROVIDED A 3RD DEGREE BURN BUT NO TREATMENT WAS PROVIDED.

  Patient problems: Hyperemia; No Code Available

  MAUDE report 9263204 ↗
• InjuryOct 31, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, USING THE RETURN ELECTRODE MONITORING (REM) PAD THE PATIENT HAD A SKIN LESION AND HYPEREMIA AT THE PLACE OF PAD. INFORMATION COULD NOT BE CLEARLY PROVIDED ON THE DEGREE OF THE BURN. TREATMENT WAS PROVIDED BY THE DRESSING COMMITTEE.

  Patient problems: Hyperemia; No Code Available

  MAUDE report 9263196 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A CHOLECYSTECTOMY PROCEDURE, HYPEREMIA WAS FOUND AT THE SITE OF THE DEVICE ON THE CALF. THE PATIENT WAS ALSO NOTED TO HAVE DEVELOPED BULLOUS LESIONS AT THE SITE OF THE DEVICE. INFORMATION COULD NOT BE CLEARLY PROVIDED ON THE DEGREE OF THE BURN OR TREATMENT PROVIDED. PICTURES WERE PROVIDED AND ONE OF THE PICTURES SHOWED WHAT APPEAR TO BE A 3RD DEGREE BURN, HOWEVER THE PATIENT IN THE PICTURE IS UNKNOWN.

  Patient problems: Full thickness (Third Degree) Burn; No Code Available; Partial thickness (Second Degree) Burn

  MAUDE report 9216085 ↗
• MalfunctionSep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PATIENT HAD A BURN. THE EQUIPMENT WAS REMOVED AND THEN FURTHER SURGERY WAS WITH A SALES DEMO UNIT AND NO BURNING OCCURRED WITH DEMO MACHINE AND SURGERY WAS PERFORMED SUCCESSFULLY. SKIN PREP ON THE WAS NOT DONE PRIOR PLACING THE PAD; IT WAS DONE ON DRY SKIN.

  Patient problems: Burn(s)

  MAUDE report 8986530 ↗
• MalfunctionJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PATIENT HAD A BURN IN THE BACK MUSCLE OF THE COXA WITH RED SPOTS AND SOME BUBBLES AT THE LOCATION OF THE PLATE.

  Patient problems: Burn(s)

  MAUDE report 8695792 ↗
• MalfunctionMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PATIENT HAD A BURN.

  Patient problems: Burn(s)

  MAUDE report 8621148 ↗
• MalfunctionMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THERE WAS A 1ST DEGREE BURN AROUND THE LEG WHERE THE ELECTRODE WAS PLACED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8441150 ↗