Valleylab LS10 VLLS10GEN (UDI 10884521780583)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521780583), received between Jul 14, 2023 and Jun 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, THE DEVICE WAS NOT SEALING. THE LS10 EQUIPMENT AND POWER CABLE WERE EXCHANGED, BUT THE PROBLEM PERSISTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 22299193 ↗
• MalfunctionJun 20, 2025Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, THE DEVICE WAS NOT SEALING. THE LS10 EQUIPMENT AND POWER CABLE WERE EXCHANGED, BUT THE PROBLEM PERSISTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 22297025 ↗
• MalfunctionDec 10, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL GASTRECTOMY, AT THE BEGINNING, THE DEVICE WAS UNABLE TO COAGULATE THE MESENTERIC BLOOD VESSEL ALTHOUGH THE HARDWARE SCREEN SHOWED THE CIRCLE WAS COMPLETED. VESSEL THICKNESS WAS 2-3 MILLIMETERS. ENERGY DELIVERY WAS NOTED AND NO ERROR TONES WERE HEARD. TRIED SEVERAL TIMES TO CHANGE THE LOTS OF DEVICE, GENERATORS, AND EVEN POWER CHARGING LINES BUT THE EFFECT WAS THE SAME. THERE WAS A BLOOD LOSS OF 20 MILLILITERS; NO BLOOD TRANSFUSION WAS REQUIRED. THE JAWS WERE CLEAN AND FRESH, WITHOUT ESCHAR. THE PROCEDURE WAS NOT COMPLETED IN A VERY PLEASANT MOOD. THE GENERATOR HAS BEEN UPDATED TO SOFTWARE 4.0.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20892470 ↗
• MalfunctionApr 26, 2024Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING HEMICOLECTOMY, INABILITY TO COMPLETE SEALING AND BLEEDING ARE OBSERVED. THE DEVICE CONSTANTLY GAVE THE WARNING THAT THE SEALING HAS BEEN COMPLETED, BUT SEALING WAS NOT COMPLETED AND THE PATIENT BLEEDS AFTER CUTTING. THE VESSEL WAS NOT FULLY TRANSECTED USING THE FIRST DEVICE, WHILE VESSEL WAS FULLY TRANSECTED ON THE SECOND DEVICE. BLEEDING OBSERVED DIRECTLY FROM THE SEAL. NO SEAL WAS COMPLETED. NO BLOOD TRANSFUSION REQUIRED. ANOTHER DEVICE USED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19198209 ↗
• MalfunctionApr 25, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LIGASURE DID NOT COAGULATE AND HAD NO SEAL. THERE WAS NO EVIDENCE OF ENERGY DELIVERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181677 ↗
• MalfunctionJan 26, 2024Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE, THE HANDPIECE HAD NO SEAL (NO EVIDENCE OF ENERGY DELIVERY) AND WAS DIFFICULT TO ACTIVATE. THERE WAS A RE-GRASP ALERT AND ERROR TONE HEARD. THE JAWS WERE CLEANED WHEN THE HANDPIECE IS NOT AT USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589080 ↗
• MalfunctionJul 14, 2023Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SURGEON STATED THAT THE FORCEPS DID NOT MAKE AN ADEQUATE SEAL AND AFTER SEALING THE TISSUE REMAINED BLEEDING. NO RE-GRASP ALERT, THERE WAS AN END TONE AND ENERGY DELIVERED. THE VLLS10GEN TEAM DID NOT REPORT INCOMPLETE SEAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17326028 ↗