Valleylab CVPLP2000 (UDI 10884521834613)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521834613), received between Jan 11, 2024 and May 4, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE ELECTRODE THAT CAME ATTACHED WITH THE SMOKE PENCIL HAD BROKE IN HALF. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068500 ↗
• MalfunctionFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE SURGEON WAS USING THE PENCIL AND IT BURNT THROUGH BOTH THE SURGEON'S GLOVES AND INJURED HIS FINGER.

  Patient problems: Burn(s)

  MAUDE report 24259559 ↗
• MalfunctionJan 16, 2026

  SURGEON USING BOVIE PENCIL, IT BURNT THROUGH BOTH GLOVES AND INJURED HIS FINGER.

  Patient problems: Unspecified Skin and Subcutaneous Tissue Problem

  MAUDE report 24093552 ↗
• MalfunctionOct 23, 2025Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A C-SECTION, THE FELLOW WAS USING THE BOVIE PENCIL AND WAS STARTING TO GO THROUGH THE PATIENT'S FASCIA WHILE THE SURGEON WAS HOLDING THE SKIN BACK. THE SURGEON WAS ON THE RIGHT SIDE OF THE PATIENT AS WELL AS THE GROUNDING PAD WHICH WAS PLACED ON THE RIGHT THIGH, AND THE GENERATOR WAS ALSO ON THE RIGHT SIDE. THE POWER ON THE FX WAS AT 35/35. THE SURGEON SAID THERE WAS A HOLE IN HER GLOVE AND SHE WAS DOUBLE GLOVED. THE SURGEON FELT HEAT AND A LITTLE JOLT. THE SURGEON FELT A PAIN THAT WENT UP HER RIGHT ARM AND ACROSS HER CHEST TO HER HEART. THE SURGEON REPORTED TO FEEL NOT RIGHT AND HER HEART STARTED TO RACE. THE SURGEON BACKED AWAY FROM THE TABLE AND THEY HAD TO CALL CODE BLUE, HOWEVER, THE SURGEON WAS ABLE TO AMBULATE OUT OF THE OPERATING ROOM INDEPENDENTLY, AND RESUSCITATION WAS NOT REQUIRED. A NEW GENERATOR AND BOVIE PENCIL WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT AND THE BABY WAS NOT HARMED/INJURED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Electric Shock; Tachycardia

  MAUDE report 23367404 ↗
• MalfunctionFeb 25, 2025Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SMOKE EVACUATOR PENCIL HAD STARTED SPARKING THROUGHOUT THE PROCEDURE AND THEN HAD A 4MM (MILLIMETERS) FLAME AT THE END OF THE ELECTRODE. THERE WAS NO OPERATING ROOM FIRE OCCURRED AND THERE WAS NOT AN ACTUAL FIRE THAT NEEDED TO BE EXTINGUISHED. THE GENERATOR WAS SWITCHED OUT TO SEE IF THAT WAS AN ISSUE AND IT ULTIMATELY WAS DETERMINED THAT IT WAS A SMOKE PENCIL ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464220 ↗
• MalfunctionFeb 18, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THERE WAS AN OPERATING ROOM FIRE. DRAPES CAUGHT FIRE DUE TO THE USE OF AN ALCOHOL-BASED CLEANING AGENT ON THE PATIENT WHEN THE PENCIL WAS ACTIVATED. THE PENCIL WAS REPORTEDLY SPARKING EXCESSIVELY AT THE TIME OF THE INCIDENT. THE FIRE WAS SMALL, STARTED ON THE PATIENT¿S ELBOW AND WENT UPWARDS TO THE SHOULDER. THE FIRE WAS EXTINGUISHED BY PATTING IT OUT AND POURING SALINE FROM THE BACK TABLE ONTO BOTH THE DRAPES AND THE PATIENT¿S ARM. THE BURN ON THE PATIENT WAS DIAGNOSED AS A 2ND-DEGREE BURN, SIZE OF A QUARTER. THE BURN SITE WAS COVERED WITH A SURGICAL DRESSING. THE GENERATOR AND HAND PIECE WORKED NORMALLY. THE ALCOHOL-BASED CLEANING AGENT WAS NOT DRY AND IGNITED WHEN EXPOSED TO ELECTROSURGICAL. THE PROCEDURE WAS COMPLETED USING THE NEW GENERATOR AND DEVICE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21404053 ↗
• MalfunctionJul 12, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LEFT AXILLARY LYMPH NODE DISSECTION, DURING DISSECTION OF TISSUE WITHIN SURGICAL SITE, THE ELECTRODE WITH THE SAFETY SLEEVE WAS PULLED FOR A CASE. THE SCRUB TECH WHEN REALIZING IT WAS NOT COMPATIBLE WITH THE CVPLP2000, ATTEMPTED TO CUT THE SAFETY SLEEVE OFF, AND THEN FORCED THE ELECTRODE ONTO THE BOVIE PENCIL WITH A PAIR OF GRASPERS OR SIMILAR DEVICE AND THAT TORE THE INSULATED LINING ON THE BOVIE PENCIL, CAUSING AN ALTERNATE PATHWAY FOR THE ELECTRICITY WHICH CAUSED THE PATIENT SMALL 1CM BURN INSIDE THE SURGICAL DISSECTION SITE UP TO THE EDGE OF THE INCISION. ITEMS LISTED WERE REPLACED AND ITEMS INVOLVED WERE SEQUESTERED IN ORDER TO COMPLETE THE CASE. THE BURN HAS BEEN BANDAGED, AND THE PATIENT IS DOING WELL WITH NO CONCERNS.

  Patient problems: Burn(s)

  MAUDE report 19735793 ↗
• MalfunctionFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TONSILLECTOMY, THE MEGADYNE ELECTRODE WAS NOT PROPERLY SEEDED IN THE CVPLP2000 PENCIL. WHEN THE PROCEDURE WAS COMPLETED THERE WERE 2 SECOND DEGREE BURNS ON THE CORNERS OF THE PATIENT'S MOUTH. THERE WAS NO ISSUE WITH GENERATOR, IT WAS JUST USED IN THE PROCEDURE TO COMPLETE THE CIRCUIT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18671035 ↗
• MalfunctionFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DUPLICATE OF PE (B)(4). ACCORDING TO THE REPORTER, THERE WAS PATIENT BURN ON BREAST SKIN.

  Patient problems: Burn(s)

  MAUDE report 18661753 ↗
• MalfunctionFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WAS PATIENT BURN ON BREAST SKIN.

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

  MAUDE report 18631282 ↗
• MalfunctionJan 11, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD AN UNKNOWN INSULATION ISSUE THAT CAUSED A FIRST DEGREE BURN TO THE PATIENT. THE BURN WAS A SIZE OF A QUARTER ON THE LEFT BREAST FROM SMOKE PENCIL. THE BURN WAS CLEANED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18499527 ↗