Valleylab E7509BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884524001012), received between Sep 26, 2017 and Aug 26, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 22892573 ↗
• MalfunctionApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD CABLE AND CORD ISSUE. THERE WAS A BURN AT THE SITE OF THE GROUNDING PAD ON THE LEFT POSTERIOR THIGH. THE SALES REPRESENTATIVE WAS NOT PRESENT WHEN BURN WAS DISCOVERED. NO WARNING, ALARMS OR UNUSUAL GENERATOR OUTPUTS. THE HEALTHCARE PROFESSIONAL HAS NO FURTHER INFORMATION FOR MEDTRONIC.

  Patient problems: Burn(s)

  MAUDE report 14114396 ↗
• MalfunctionNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS AN ARCHING FROM A NON-MEDTRONIC CAUTERY PENCIL AND THE 8X4 RADEK CAUGHT FIRE IN THE SURGICAL FIELD. THE BIOMED TEAM CHECKED THE GENERATOR AND EVERYTHING CAME BACK FINE.

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

  MAUDE report 12805893 ↗
• MalfunctionMar 12, 2019Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE WAS USED WHEN PATIENT HAD BURN TO ABDOMEN SITE. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Burn(s)

  MAUDE report 8414366 ↗
• InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIA OPERATION, THERE WAS A SMALL BILLOW OF SMOKE WITH NO FLAME WHICH LED TO AN INVESTIGATION UNDER DRAPES. THE PATIENT HAD TO EXTEND HOSPITALIZATION BY ONE NIGHT AND HAD ONGOING TREATMENT AT THE BURNS UNIT FOR HIS BURN SITES WHICH WILL SCAR LOCATED UNDER THE UMBILICUS AT 3X50P SIZE. THE WOUND WAS TREATED WITH SAVLON SOAKED GAUZE AND THEN REPLACED WITH CLEAN DRESSING.

  Patient problems: No Code Available

  MAUDE report 8199496 ↗
• MalfunctionSep 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED "ESFACELACION" FROM THE PAD RESULTING IN A TEMPORARY INJURY TO THE PATIENT. THE INCIDENT GROUNDING PAD WAS DI SCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6895690 ↗