V-Loc 180 VLOCL2145Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521131545), received between Oct 9, 2017 and Jan 3, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN REMOVED FROM THE PACKAGING, THE THREAD WAS DISCONNECTED FROM THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068756 ↗
• MalfunctionMay 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE DETACHED WHILE REMOVING FROM THE PACKAGING. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963219 ↗
• MalfunctionFeb 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DISCONNECTED FROM THE STITCH WITH MINIMAL EFFORT.

  Patient problems: Insufficient Information

  MAUDE report 16453918 ↗
• MalfunctionFeb 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CLOSURE OF THE VAGINAL VAULT AT THE END OF THE PROCEDURE, THE SURGEON WAS SUTURING LAPAROSCOPICALLY WITH THE SUTURE WHEN THE TAIL BROKE. THE SUTURE NEEDLE AND TAIL WERE REMOVED FROM THE PATIENT CAVITY. ANOTHER SUTURE WAS USED TO SUTURE THE VAGINAL VAULT CLOSED IN THE SAME MANNER. ONCE AGAIN THE SUTURE TAIL BROKE WHILE THE SURGEON WAS USING IT TO APPROXIMATE SKIN. PATIENT HAD AN INCREASED TIME UNDER ANESTHESIA. THE SURGEON WAS ABLE TO CLOSE THE VAGINAL VAULT WITH A DIFFERENT SUTURE AND THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386489 ↗
• MalfunctionJan 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A ROBOTIC LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE NEEDLE POPPED OFF THE STRAND PREMATURELY WHILE SEWING IN THE HERNIA MESH USING THE RUNNING STITCH TECHNIQUE. THE SURGEON HAD TO CUT THE STRAND AND USE A NEW SUTURE TO CONTINUE SEWING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099807 ↗
• InjuryJul 29, 2022Material Frayed; Unraveled Material; Adverse Event Without Identified Device or Use Problem; Material Frayed; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, 13 WEEKS AND 4 DAYS AFTER TOTAL LAPAROSCOPIC HYSTERECTOMY, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH BLEEDING AND VAGINAL PAIN. VAGINAL CUFF REPAIR WAS PERFORMED TO FIX THE ISSUE.

  Patient problems: Anxiety; Distress; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 15132346 ↗
• MalfunctionMar 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINOPLASTY, BOTH NEEDLE AND THREAD BROKE. ANOTHER DEVICE WAS USED. IT WAS STATED THAT THERE WERE TWO DEVICES INVOLVED ON THE SAME CASE. ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412711 ↗
• MalfunctionOct 9, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE THREAD OF THE SUTURE BROKE. IT OCCURRED WHEN PASSING NEEDLE THROUGH THE LOOP. THEY OPENED A NEW DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6929117 ↗