Valleylab E2515HRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10884524000046), received between Jul 27, 2017 and Apr 28, 2026 — classified as 7 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Fire” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE CLOSING ON THE RIGHT BREAST INCISION SITE, THE INSULATED PORTION OF THE PENCIL TIP CONTACTED THE PATIENT'S SKIN AND CAUSED A SMALL BURN. THE PENCIL ITSELF WAS ALSO NOTED TO BE HOT TO THE TOUCH BY THE FA IN THE OR.

  Patient problems: Burn(s)

  MAUDE report 25017630 ↗
• InjuryApr 6, 2026Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS NOT RECOGNIZED BY THE UNIT, RESULTING IN AN ACTIVATION ISSUE AND DIFFICULTY ACTIVATING THE DEVICE. THE PROCEDURE WAS ABORTED.

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

  MAUDE report 24793695 ↗
• InjuryApr 6, 2026Difficult or Delayed Activation; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD DIFFICULTY ACTIVATION AS IT WAS NOT RECOGNIZED BY THE EQUIPMENT. THERE PROCEDURE WAS ABORTED.

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

  MAUDE report 24793597 ↗
• MalfunctionJul 15, 2025Tear, Rip or Hole in Device Packaging

  WHILE OPENING SUPPLIES FOR SURGICAL PROCEDURE THE VALLEYLAB ROCKER PENCIL WAS NOTED TO ACTUALLY HAVE THE TIP PIERCED THROUGH THE PLASTIC HOLSTER AND STERILE PACKAGING. SUPPLY KEPT AND HANDED OVER TO MATERIALS MANAGEMENT. NEW SUPPLIES OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506291 ↗
• InjuryApr 16, 2025Failure to Fire; Appropriate Device Problem Term/Code Not Available; Failure to Fire; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE DEVICE, THERE WAS AN ACTIVATION ISSUE WHERE THE DEVICE DID NOT ACTIVATE, LEADING TO THE CANCELLATION OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21851208 ↗
• MalfunctionJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGEON HAD A 2MM 1ST DEGREE BURN IN THE FINGER WHILE USING THE DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21233078 ↗
• MalfunctionJan 17, 2025Unintended Power Up; Unintended Power Up

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS REPORTED THAT THE DEVICE ACTIVATED WHEN UNINTENDED WHICH WAS ATTRIBUTED TO USER ERROR DUE TO THE ACTIVATION BUTTON'S LOCATION OR DESIGN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186054 ↗
• MalfunctionAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER ANUS SURGERY WITH JACK-KNIFE POSITION, OPERATION ROOM NURSE FOUND A BURN MARK APPROXIMATELY 2.5 CM ON THE THIGHS ON THE OTHER SIDE WHERE THE NON-MEDTRONIC PLATE WAS NOT ATTACHED. AN INCORRECT OUTPUT WAS GENERATED FROM THE GENERATOR, CAUSING BURN IN THE PATIENT. THE BURN DEGREE WAS UNKNOWN, BUT NOT A FATAL BURN. THE PATIENT ONLY RECEIVED INITIAL TREATMENT AND DECIDED TO RECEIVE TREATMENT AT ANOTHER HOSPITAL.

  Patient problems: Burn(s)

  MAUDE report 19912146 ↗
• MalfunctionFeb 12, 2024Fire; Melted; Fire; Melted

  ACCORDING TO THE REPORTER, THE PENCIL WAS CAUGHT IN FIRE (SMALL FLAMES) AND MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691050 ↗
• MalfunctionFeb 8, 2024Fire; Failure to Fire; Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING USE, TWO OF THE PENCILS DID NOT WORK AT ALL WHEN REMOVED FROM THE PACKAGE AND PLUGGED IN. ONE IGNITED A SMALL FLAME WHILE IN USE THAT WAS IMMEDIATELY EXTINGUISHED.

  Patient problems: Insufficient Information

  MAUDE report 18670843 ↗
• MalfunctionMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TONSILLECTOMY, THE BOVIE PENCIL BURNED INSIDE OF CHILD'S MOUTH, IT WAS A SUPERFICIAL (FIRST DEGREE) BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16958540 ↗
• MalfunctionFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SWITCH PENCIL WAS PLACED ON THE DRAPE MOMENTARILY AT WHICH TIME IT STARTED TO BURN A HOLE IN THE DRAPE, IT WAS CHANGED TWICE BUT IT WAS STILL HAPPENING, THERE WAS NO VISIBLE FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418627 ↗
• MalfunctionFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE VALLEYLAB ROCKER SWITCH PENCIL WAS PLACED ON THE DRAPE MOMENTARILY AT WHICH TIME IT STARTED TO BURN A HOLE IN THE DRAPE, IT WAS CHANGED TWICE BUT IT WAS STILL HAPPENING, THERE WAS NO VISIBLE FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418064 ↗
• InjuryJan 26, 2023Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TRACHEOSTOMY, WHILE MAKING AN INCISION TO PERFORM THE PROCEDURE, THE SPARKS FLEW FROM THE PENCIL AND MADE A SMALL FIRE WITH THE SURROUNDING FABRIC THAT CAUSED THE BURN AROUND PATIENT'S NECK. THE SMALL FIRE WAS EXTINGUISHED BY COVERING WITH ANOTHER CLOTH. THERE WAS A TEMPORARY INJURY WHICH WAS A MICROBURNS ON SKIN AROUND THE PATIENT'S NECK WITH THE SIZE OF 1 CENTIMETER. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC PRODUCT. PHOTOS WERE SUBMITTED AND THE TIP OF THE PENCIL HAD A BURN MARK. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION AS WELL AS EXTENDED HOSPITALIZATION.

  Patient problems: Burn(s)

  MAUDE report 16250118 ↗
• MalfunctionDec 1, 2022Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE CLIP BREAKS OFF.

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

  MAUDE report 15896130 ↗
• MalfunctionJun 20, 2022Device Alarm System; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS CANCELLED AS THERE WAS AN ERROR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14745994 ↗
• MalfunctionJun 20, 2022Device Alarm System; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE. PROCEDURE WAS CANCELLED AS AN ERROR HAD OCCURRED. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14745438 ↗
• MalfunctionJun 16, 2022Device Alarm System; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDPIECE WAS DIFFICULT TO ACTIVATE AND AN ERROR OCCURRED. PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717321 ↗
• MalfunctionJun 9, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, TWO DEVICES HAD THE SHEATH PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14648812 ↗
• MalfunctionJun 9, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, TWO DEVICES HAD THE SHEATH PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14648720 ↗
• MalfunctionJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE ELECTRO CAUTERY BOVIE PENCIL HAD OPENING WHERE IT JOINED TOGETHER AND BURNED PATIENT'S LIP. CAME IN A MIN PACK THAT CONTAINS ROCKER WITH HOLSTER.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 14634750 ↗
• MalfunctionMar 30, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN ENT (EAR, NOSE, THROAT) PROCEDURE, THE BOVIE HAD A MALFUNCTION AND THE PATIENT'S MOUTH WAS BURNED. THE AFFECTED AREA WAS FIRST TREATED WITH A SALINE SOAKED GAUZE THEN WITH A SILVADENE CREAM. THE PROCEDURE WAS NOT EXTENDED BY 30 MINUTES.

  Patient problems: Burn(s)

  MAUDE report 13951188 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PENCIL MALFUNCTIONED AND BURN THE SIDE OF THE MOUTH. PATIENT INADVERTENTLY BURNED FROM THE METAL THAT WAS EXPOSED ON ELECTRODE WHERE IT PLUGS INTO THE BOVIE PENCIL. ELECTRODE AND GENERATOR USED ALONG WITH THE PENCIL WERE NON-MEDTRONIC PRODUCTS.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 13929506 ↗
• MalfunctionFeb 22, 2022Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A FACIAL SURGICAL PROCEDURE, WHEN THE UNIT BEGUN IN COAGULATION MODE TOGETHER WITH AN ACTIVE ELECTRODE AND AN ELECTRODE NEUTRAL, IT GENERATED A SPARK THAT CAUSED A BURN TO THE PATIENT. THE PATIENT HAD AN OXYGEN CANNULA.

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

  MAUDE report 13577843 ↗
• MalfunctionJan 27, 2022Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PASSAGE OF HEMOSTASIA OF THE CRUENT AREA OF THE RESECTION OF BASOCELLULAR CARCINOMA, A COMPLICATION OCCURRED IN WHICH THE PATIENT HAD BURN IN THE NASAL TIP, NASOGENIAN GROOVE, NASAL WINGS, UPPER SKIN LIP AND MEDIAL EDGES OF THE CHEEKS. THE BURN WAS IMMEDIATELY WASHED WITH 1000 CC OF SALINE SOLUTION AND OCCLUSIVE CUTTING WITH MICROPORE, PUT MEDICAL ADHESIVE AND PAIN MODULATION WITH ACETAMINOPHEN. IT WAS ALSO NOTED THAT DURING THE SURGICAL PROCEDURE, A SURFACE SECOND DEGREE BURN COMPLICATION OCCURRED BECAUSE THE OXYGEN INTERACTIONS WITH THE ELECTROCAUTERY. THERE WAS A FIRE UNDER THE PATIENT'S FACEMASK.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13366165 ↗