Valleylab E2520HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884524000961), received between Jul 10, 2018 and Jan 11, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

25 other recalls cover devices cleared under the same FDA submission (K926481); they may or may not involve this specific model.

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.

• MalfunctionJan 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, DURING THE RETRACTION OPERATION OF THE ELECTRODE OF THE ARGON HANDSET, THE SLIDE OPERATION WAS MORE ASTRINGENT (STIFFER) THAN USUAL (3 PIECES), AND WHEN THE ELECTRODE WAS PULLED OUT IN AN ATTEMPT TO REPLACE WITH ANOTHER ONE, NOT ONLY THE ELECTRODE BUT ALSO THE METAL PART ON THE RECEIVING SIDE OF THE ELECTRODE CAME OFF TOGETHER. (2 PIECES). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13230905 ↗
• MalfunctionOct 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED, REMOVING THE TIP OF THE METAL CORE THE LATTER WAS COMING OFF MAKING THE DEVICE UNUSABLE. REPLACED WITH NEW DEVICE TO PROCEED WITH THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10677164 ↗
• MalfunctionSep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PNEUMONECTOMY PROCEDURE, THE SURGEON BURNED HIS THUMB WHEN USING THE HAND PIECE.

  Patient problems: Burn(s)

  MAUDE report 10537751 ↗
• MalfunctionJan 7, 2020Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, GENERAL SURGEON HAD FORGOTTEN TO REMOVE EXISTING ELECTRODE FROM THE ARGON HANDSET AND PLUGGED A LAPAROSCOPIC ARGON ELECTRODE INTO THE END RECEPTACLE. WHEN THE HANDSET GOT ACTIVATED, THE DEVICE SPARKED WHEREIN THE PATIENT HAD A BUN.

  Patient problems: Burn(s)

  MAUDE report 9559994 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LIVER MASS BIOPSY, THE UNIT'S HAND PIECES WOULD NOT FIRE PROPERLY - IT WAS VERY WEAK AND NEVER ARCED PROPERLY. HAD IT TURNED ALL THE WAY UP AND BOTH TANKS WERE FULL. HAD TO OPEN THE PATIENT (CONVERTED TO LAPAROTOMY) TO CONTROL BLEEDING. OPENED MULTIPLE DEVICES, USED CAUTERY AND ENDO TIES TO COMPLETE THE SURGERY.

  Patient problems: No Code Available

  MAUDE report 8514179 ↗
• MalfunctionJul 10, 2018Flare or Flash; Temperature Problem; Flare or Flash

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A NURSE HAD TOUCHED THE MONOPOLAR NEAR THE ADAPTOR AND THE NURSE HAD MINIMAL BURN.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 7673994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K926481. One submission often covers many models, so check the product and lot details in each record.

• Z-2554-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoraco
• Z-2560-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracosc
• Z-2569-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic s
• Z-2575-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoraco
• Z-2577-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thorac
• Z-2570-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and
• Z-2557-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic
• Z-2555-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thora
• Z-2565-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgi
• Z-2556-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thora
• Z-2561-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic
• Z-2571-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surg
• Z-2573-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgi
• Z-2558-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracosc
• Z-2562-2016 · Jul 8, 2016 · Terminated
  Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic su

…and 10 more.