V-Loc 180 VLOCL0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521130944), received between Oct 15, 2019 and Dec 25, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jun 24, 2026Class IIOpen, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, PRIOR TO PATIENT USE, THERE WAS NO LOOP AT THE END OF THE SUTURE UPON OPENING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894359 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE SUTURING THE 3 SUTURES IN THE CASE BROKE IN THE MIDDLE. ANOTHER SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838619 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE SUTURING THE (B)(4) SUTURES IN THE CASE BROKE IN THE MIDDLE. ANOTHER SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838594 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY, WHILE CLOSING THE SEROSAL LAYER OF THE UTERUS, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725777 ↗
• MalfunctionNov 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE SUTURING THE 12 SUTURES IN THE CASE BROKE IN THE MIDDLE. ANOTHER SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23563932 ↗
• MalfunctionAug 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC MYOMECTOMY, WHILE SUTURING, THE NEEDLE DETACHED FROM THE STRAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919068 ↗
• InjuryMay 15, 2024Break; Break

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE THREAD BROKE. THE PATIENT CAME BACK AFTER HAVING HAD A LAPAROSCOPIC HYSTERECTOMY AND STARTED TO HAVE PAIN AND BLEEDING SEVERAL WEEKS AFTER THE PROCEDURE. THE PATIENT HAD TO BE REOPERATED DUE TO BREAKAGE OF VAGINAL CLOSURE, ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19320892 ↗
• InjuryMay 9, 2024Break; Break

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE THREAD BROKE. THE PATIENT CAME BACK AFTER HAVING HAD A LAPAROSCOPIC HYSTERECTOMY AND STARTED TO HAVE PAIN AND BLEEDING SEVERAL WEEKS AFTER THE PROCEDURE. THE PATIENT HAD TO BE REOPERATED DUE TO BREAKAGE OF VAGINAL CLOSURE, ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19280369 ↗
• InjuryMay 1, 2024Break; Break

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE THREAD BROKE. THE PATIENT CAME BACK AFTER HAVING HAD A LAPAROSCOPIC HYSTERECTOMY AND STARTED TO HAVE PAIN AND BLEEDING SEVERAL WEEKS AFTER THE PROCEDURE. THE PATIENT HAD TO BE RE-OPERATED DUE TO BREAKAGE OF VAGINAL CLOSURE, ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19221402 ↗
• MalfunctionMar 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE, WHILE HERNIA SUTURING, THE THREAD BROKE WHILE PULLING THE THIRD THROW OF A RUNNING SUTURE. THE NEEDLE WAS LOCATED SAFELY AND REMOVED FROM THE ABDOMEN. IT WAS NOTED THAT THE ABSORBABLE SUTURE WAS OPENED OR REMOVED FROM THE PACKAGING 15-20 MINUTES PRIOR TO USE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564697 ↗
• MalfunctionNov 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE'S NEEDLE DETACHED FROM THE THREAD.

  Patient problems: No Information

  MAUDE report 10796135 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY, 203 PATIENTS UNDERWENT MYOMECTOMY BY TWO SPECIALISTS BETWEEN 2014 AND 2017. 110 WOMEN UNDERWENT LAPAROSCOPIC MYOMECTOMY, AND 93 WOMEN UNDERWENT ROBOT-ASSISTED LAPAROSCOPIC MYOMECTOMY. IN ALL PROCEDURES, THE LIGASURE WAS USED TO MAKE A LINE INTO THE MYOMETRIUM AND DEEPENED UNTIL THE MYOMA SURFACE APPEARED. AFTER THE MYOMA WAS REMOVED, THE LIGASURE WAS USED TO SEPARATE THE CAPSULE FROM THE MYOMA. THE MYOMETRIAL WOUND WAS REPAIRED USING V-LOC. SEVEN DAYS POST-OPERATIVELY, SIX PATIENTS DEVELOPED A HEMATOMA, ONE OF WHICH ALSO HAD A PELVIC INFECTION THAT NEEDED CT-GUIDED DRAINAGE OF THE HEMATOMA AND ANTIBIOTIC TREATMENT.

  Patient problems: Hematoma; Unintended Radiation Exposure; Unspecified Infection

  MAUDE report 10733305 ↗
• MalfunctionSep 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, UPON OPENING OF PACKAGING IT WAS DETERMINED THAT THE NEEDLE WAS NOT ATTACHED TO THE THREAD.

  Patient problems: No Information

  MAUDE report 10605038 ↗
• MalfunctionOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE AND THREAD SEPARATED WHILE USING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195087 ↗