Valleylab E2515HDBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884524000527), received between Jul 16, 2019 and Jul 20, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2024Device Remains Activated; Communication or Transmission Problem; Device Remains Activated; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS NOT DETECTED BY THE GENERATOR. THE DEVICE HAD ERROR CODE E322. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT, IT WAS IDENTIFIED THAT ONCE THE COAGULATION BUTTON WAS PRESSED, THE PENCIL WILL REMAINED ACTIVATED UNTIL THE PENCIL WAS UNPLUGGED FROM THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786029 ↗
• MalfunctionDec 1, 2022Self-Activation or Keying; Connection Problem; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS CONNECTED TO THE GENERATOR BUT THE GENERATOR DID NOT RECOGNIZED THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THE MEDTRONIC INITIAL EVALUATION STATED THAT THE PENCIL HAD SELF-ACTIVATION. THE DEVICE HAD AN E322 ALARM, INDICATING THE GENERATOR BELIEVES A BUTTON IS BEING PRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898995 ↗
• MalfunctionMay 27, 2020Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, THE DEVICE'S COAGULATION BUTTON STICKS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10090666 ↗
• MalfunctionDec 2, 2019Fire; Loose or Intermittent Connection; Arcing; Adverse Event Without Identified Device or Use Problem; Fire; Loose or Intermittent Connection; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, 6.5" ELECTRODE AND PENCIL WAS USED DURING CAUTERY WHEN ARCING OCCURRED CAUSING FIRE ON THE SPONGE THAT WAS ON NEARBY METAL RETRACTOR. THE ELECTRODE WAS NOT FULLY SEATED IN THE PENCIL AND FORMED A SMALL GAP, WHERE A PORTION OF THE METAL ELECTRODE WAS EXPOSED BETWEEN PENCIL AND THE ELECTRODE INSULATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397036 ↗
• MalfunctionJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TONSILLECTOMY, THE PENCIL WITH A DIFFERENT ELECTRODE HAD ARCING AND CAUSED A MILD MUCOSAL BURN NEAR THE LIP AREA OF THE PATIENT. ANOTHER ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. PATIENT WAS HEALING WELL.

  Patient problems: Burn(s)

  MAUDE report 8794400 ↗