Valleylab E7507DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884524000602), received between Nov 5, 2018 and Oct 20, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 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 CAUSE THE PATIENT TO DEVELOP A BRUISING RED, BURNING TO THE SKIN ON THE RIGHT THIGH WHERE THE PAD WAS PLACED. THE CORRECTIVE ACTION TAKEN WAS ONLY OBSERVATION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO MEDICAL NOR SURGICAL INTERVENTION DONE TO INJURED SITE.

  Patient problems: Bruise/Contusion; Burn(s); Skin Discoloration

  MAUDE report 23337616 ↗
• MalfunctionApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING HEART SURGERY, THE GROUNDING PAD WAS PLACED ON THE BUTTOCK. THE PATIENT EXHIBITED SIGNS OF BURNS AND BLISTERING IN THE BUTTOCKS 48 HOURS AFTER THE PROCEDURE, RESULTING IN A TEMPORARY INJURY.

  Patient problems: Blister; Burn(s)

  MAUDE report 21775172 ↗
• MalfunctionFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PATIENT PRESENTED WITH A BURN THAT WAS ONLY SEEN AFTER THE SURGERY. THE BURN IS UNKNOWN IF IT IS PERMANENT OR NOT. NO ONE IN THE ROOM KNEW WHAT EXACTLY HAPPENED TO THE PATIENT OR WHAT CAUSED THE BURN. THE FACILITY ALSO WANTS THE GENERATOR INSPECTED TO ENSURE THERE WERE NO ISSUES OR CHANCE OF ACTIVATION ISSUE.

  Patient problems: Burn(s)

  MAUDE report 21469851 ↗
• MalfunctionMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD A 5CM LINEAR LINE BURNS ON CALF ATTACHMENT.

  Patient problems: Burn(s)

  MAUDE report 16568352 ↗
• MalfunctionAug 16, 2022Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WERE TWO DARK CIRCULAR SPOTS NOTICEABLE ON THE PAD DIRECTLY CORRELATED TO PATIENT BURN SITES. THE PAD WAS PLACED ON BUTTOCKS AREA AND THERE WERE 2 SMALL BURN (1ST DEGREE BURN) MARKS UNDER PAD WHERE DIRECTLY UNDER THE 2 DARK CIRCLES MARKED IN THE PAD. BURN WAS TREATED WITH TOPICAL WOUND TREATMENT AND BAND AID.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15235527 ↗
• MalfunctionMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RADIOFREQUENCY ABLATION PROCEDURE, WITH A NON-MEDTRONIC GENERATOR, A PAD SITE BURN WAS NOTICED ON THE PATIENT¿S BACK AT THE END OF THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 13637003 ↗
• MalfunctionMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING RADIOFREQUENCY ABLATION PROCEDURE WITH A BIOSENSE WEBSTER STOCKERT GMBTT GENERATOR, A PAD SITE BURN ON THE PATIENT'S BACK WAS NOTICED AT THE END OF THE CASE. IT WAS REPORTED THAT THE SIZE OF THE BURN WAS UNKNOWN AND THERE WAS NO AVAILABLE PHOTO OF THE BURN SITE.

  Patient problems: Burn(s)

  MAUDE report 13634255 ↗
• MalfunctionMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON RADIOFREQUENCY ABLATION PROCEDURE WITH A COMPETITOR¿S GENERATOR, A PAD SITE BURN WAS NOTICED ON THE PATIENT¿S BACK.

  Patient problems: Burn(s)

  MAUDE report 13633948 ↗
• InjuryJan 13, 2022Difficult 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

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON THE 3 DEVICES, THERE WAS TEARING, BRUISING AND REDNESS OF SKIN UNDER THE BOVIE PAD. TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS OCCURRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13254305 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT SUFFERED A 3RD DEGREE BURN UNDER THE ADULT REM PAD. THIS WAS NOTICED IN RECOVERY. LOCATION AND SIZE OF BURN AS DESCRIBED. THE PAD'S LOCATION WAS ON THE LEFT LATERAL UPPER LEG. THE POWER SETTINGS OF THE ELECTRO-SURGICAL UNIT(ESU) WAS COAG 30 AND CUT 30 ON MONO SETTING. THE PATIENT WAS IN LITHOTOMY POSITION WHILE IN OPERATING ROOM(OR). NO COMPRESSION STOCKING WAS USED IN THE OPERATING ROOM. LENGTH OF CASE WAS 4 HOURS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 12590710 ↗
• MalfunctionNov 5, 2018Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE RETURN ELECTRODE MONITOR (REM) PAD WOULD NOT WORK. GREEN REM LIGHT WOULD BE VISIBLE ON THE ELECTROSURGICAL UNIT BUT THE DEVICES WOULD NOT SHOW ANY CLINICAL EFFECT. NURSE REPLACED THE PAD WITH ANOTHER SIMILAR PAD AND EVERYTHING WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038897 ↗
• MalfunctionNov 5, 2018Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE RETURN ELECTRODE MONITORING (REM) PAD WOULD NOT WORK. GREEN REM LIGHT WOULD BE VISIBLE ON THE ELECTROSURGICAL UNIT, BUT THE DEVICES WOULD NOT SHOW ANY CLINICAL EFFECT. NURSE REPLACED THE PAD WITH ANOTHER SIMILAR PAD AND EVERYTHING WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038018 ↗
• MalfunctionNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE RETURN ELECTRODE PAD CAUSED BURN TO PATIENT.

  Patient problems: Burn(s)

  MAUDE report 8037910 ↗