Valleylab LS10Recalls & reported problems across all models

We found 2 models of Valleylab LS10 by Covidien LP in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2017 and Sep 30, 2026 — classified as 10 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (62 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Valleylab LS10 problems

Valleylab LS10 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Valleylab LS10 VLLS10GEN

  Electrosurgical, cutting & coagulation & accessories
  67 reports
• Valleylab LS10 VLLS10GEN

  Electrosurgical, cutting & coagulation & accessories
  7 reports

Recent Valleylab LS10 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Energy Output Problem

  It was reported that during ovarian hysterectomy, the unit despite all checks, the clamp did not achieve normal hemostasis. There was energy delivery noted, no a re-grasp alert with end tone heard when apply to less than 7 mm ligament. Another new device was used but the issue remained the same. Device's handpiece was new and first cycle failed and no good seals was completed. The unit had been placed and procedure was completed with devices. The patient had bleeding but no blood transfusion needed.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50941723 ↗
• InjuryMay 28, 2026Energy Output Problem; Connection Problem

  IT WAS REPORTED THAT SIX (6) HOURS AFTER GASTRIC SLEEVE / SASI (SINGLE ANASTOMOSIS SLEEVE ILEAL BYPASS) PROCEDURE, THE PATIENT HAD 2 PINTS OF BLOOD TRANSFUSION DUE TO HYPOVOLEMIC SHOCK CAUSED BY 1500ML ENDOSCOPIC BLEEDING. A REOPERATION WAS PERFORMED TO DETECT THE BLEEDING SOURCE AND STOP THE BLEEDING. NO MASSIVE TRANSFUSION PROTOCOL (MTP) WAS INITIATED. THE EVENT REPORTEDLY EXTENDED HOSPITALIZATION FOR AN UNKNOWN DURATION AND WAS ADMITTED TO SEMI-INTENSIVE CARE UNIT. IT WAS NOTED THAT DURING A PROCEDURE, THE DEVICE HAD INADEQUATE OR PARTIAL EVIDENCE OF ENERGY DELIVERY AND END TONES BEING HEARD. THE SEAL REPORTEDLY SHOWED EVIDENCE OF ENERGY DELIVERY BUT BLED AT GASTRO-DIAPHRAGMATIC VESSELS, BACK OF THE LEFT PILLARS AFTER CUTTING, AND THE SEALING TIME OF THE VESSEL WAS OBSERVED TO BE SHORT. IT WAS NOTED THAT THE JAWS WERE CLEANED APPROXIMATELY FOUR TIMES DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoglycemic Shock; Laceration(s)

  MAUDE report 25312003 ↗
• MalfunctionJan 12, 2026Device Alarm System; Energy Output Problem; Connection Problem

  IT WAS REPORTED THAT DURING RADICAL AXILLARY LYMPH NODE DISSECTION VIA OPEN APPROACH PROCEDURE, THE DEVICE HAD NO SEAL AS THERE WAS NO EVIDENCE OF ENERGY DELIVERY AND END TONES WERE HEARD. PATIENT HAD MINIMAL BLEEDING. THE CONSOLE WAS REPLACED, AND A NEW LIGASURE CLAMP WAS REQUESTED TO COMPLETE THE PROCEDURE. UPON NOTICING THAT IT WAS NOT FUNCTIONING PROPERLY, THE DECISION WAS MADE TO FINISH THE PROCEDURE WITH A NON-MEDTRONIC HANDPIECE. VIDEO RECEIVED AND SHOWED THAT THE THERE WAS A START TONE FOLLOWED BY END TONE, HOWEVER THE GENERATOR SHOWED AMBER LIGHT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24034885 ↗
• MalfunctionOct 27, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT WAS NOT SEALING PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392169 ↗
• MalfunctionSep 26, 2025Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LIGASURE DEVICE OF THE UNIT HAD POOR BURNING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23153235 ↗
• InjuryAug 15, 2025Device Displays Incorrect Message; Connection Problem; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, IMMEDIATELY AFTER CONNECTION, THE DEVICE WAS NOT RECOGNIZED BY THE GENERATOR SHOWING ERROR MESSAGE OF RED TRIANGLE WITH 3 BEEPS. THE PHYSICIAN COULD NOT DO THE PROCEDURE AND SET OFF SOME OTHER TIME.

  Patient problems: Insufficient Information

  MAUDE report 22814636 ↗
• MalfunctionJul 10, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE COAGULATION OF THE UNIT DID NOT WORK PROPERLY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22467353 ↗
• 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 ↗
• InjuryJun 7, 2025Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE DEVICE INITIALLY FUNCTIONED PROPERLY. IT WOULD SEAL WITH EVIDENCE OF ENERGY DELIVERY AND END TONE BUT THERE WAS NO REGRASP ALERT. THE DEVICE WOULD CUT WHEN THE JAWS WOULD NOT OPEN AFTER ABOUT ONE HOUR AND WAS UNABLE TO BE USED. DESPITE THIS, THE POWER APPEARED TO STILL BE REACHING THE DEVICE, AS IT CONTINUED TO MAKE THE USUAL SOUNDS WHEN THE ENERGY BUTTONS WERE PRESSED. ON DAY TWO AFTER THE OPERATION, THE PATIENT HAD APPROXIMATELY 500ML OF BLEEDING DUE TO DIFFICULTY OF ADEQUATELY SEALING OF TRANSECTED OMENTUM AND RETROPERITOBAL TISSUE THAT WAS SELF-LIMITING BUT RESULTED IN A PROLONGED ILEUS. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED BY THREE DAYS, RESULTING IN A TOTAL HOSPITAL STAY OF EIGHT DAYS, DUE TO A DELAYED RETURN OF BOWEL FUNCTION. THE PROCEDURE WAS COMPLETED USING CLIPS AND DIATHERMY LAPAROSCOPICALLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22162806 ↗
• MalfunctionApr 9, 2025Failure to Calibrate; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT HAD A LEAKAGE AND THE ANIMAL PATIENT HAD A FIRST-DEGREE BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21809095 ↗
• MalfunctionJan 24, 2025Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT HAD SEAL INCOMPLETE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234826 ↗
• MalfunctionJan 24, 2025Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO REPORTER, DURING TESTING, THE DEVICE HAD SEAL INCOMPLETE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229442 ↗
• MalfunctionDec 27, 2024Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE WAS NOT WORKING PROPERLY. THE SURGEON WAS NOT GETTING THE SEAL HE WOULD NORMALLY EXPECT TO SEE AND IT WAS ONLY SEALING VERY MINIMALLY AND LOOKED FAINT. THE MACHINE GAVE THE TWO-TONE BLEEP AND THE SOUND EMITTED WAS FAINT, HE SAID THAT THE MACHINE WAS NOT ALARMING. HE REQUESTED A SECOND HANDPIECE BE OPENED AND THIS PERFORMED IN A SIMILAR WAY INITIALLY UNTIL HE DECIDED TO ASK THEM TO CHANGE THE LS10 MACHINE. ON USING A REPLACEMENT MACHINE, THE SECOND HANDPIECE WORKED AS NORMAL. THE UNIT WAS SENT TO ELECTRICAL ENGINEERING DEPARTMENT FOR CHECKING. THEY TESTED WITH A NEW HANDPIECE ON DAMP TISSUE AND SAID IT ALL APPEARED OK AND HAVE PUT THE MACHINE BACK INTO CIRCULATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028188 ↗
• 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 ↗

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