Valleylab E1551-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521713291), received between Jul 30, 2018 and Sep 21, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Arcing” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 50849353 ↗
• MalfunctionJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT'S SKIN WAS BURNED IN THE LEFT MIDAXILLARY LINE DURING THE PROCEDURE. AT THE COMPLETION OF THE PROCEDURE, MEDICATION WAS ADMINISTERED AND COVERED WITH DRESSING, WITH FOLLOW-UP WOUND CARE REQUIRED IN 48 HOURS. THE SIZE AND DEGREE OF BURN WAS NOT SPECIFIED.

  Patient problems: Burn(s)

  MAUDE report 22542187 ↗
• MalfunctionJan 10, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN CHANGE OF BREAST PROSTHESIS PROCEDURE, THERE WAS APPEARANCE OF ELECTRIC ARCS AT THE BLADE/HANDLE JUNCTION AND THE PATIENT HAD A BURN ON SUBMAMMARY FOLD. THE BURN WAS CAUSED BY BOTH JUNCTIONS OF THE PENCIL AND BLADE.

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

  MAUDE report 21124517 ↗
• MalfunctionNov 27, 2024Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT ACTIVATE AND HAD COAGULATION BUTTON WAS NOT WORKING. THERE WAS INSUFFICIENT/NO COAGULATION. USED ANOTHER DEVICE WHICH WORKED WELL. THE PATIENT HAD BLEEDING. THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR REOPERATION DONE TO PATIENT TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20803003 ↗
• MalfunctionMar 6, 2023Fire; Fire

  ACCORDING TO THE REPORTER THE CAUTERY CAUGHT FIRE AT THE END OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492414 ↗
• MalfunctionMar 28, 2022Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, SURGEON WAS ELECTROCUTED, A COMPRESS WAS SET ON FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929797 ↗
• MalfunctionJun 11, 2020Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THE INSULATION OF THE DEVICE RUPTURED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10144836 ↗
• MalfunctionJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PHYSICIAN SUSTAINED A BURNING SENSATION WHEN UTILIZING THE DEVICE. THERE WAS NO VISIBLE BURN ON THE GLOVE THE SURGEON WORE. BUT WHEN THE SURGEON TOOK OFF THE GLOVE IT WAS VISIBLE ON HIS THUMB A FIRST DEGREE BURN. THE BURN WAS TREATED, WOUND CLEANED AND DRESSING APPLIED. THERE WAS NO PATIENT INJURY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8746660 ↗
• MalfunctionJul 30, 2018Arcing; Sparking; Flare or Flash; Arcing; Flare or Flash

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE ELECTRODE'S MIDDLE PART OF THE TIP WAS SPARKING ON THE STOMACH. THERE WAS A SMALL BURN ON THE STOMACH WALL AND THE BURN WAS TREATED BY SUTURING THE DAMAGED TISSUE. NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 7732767 ↗