V-Loc 180 VLOCL3216Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521215139), received between Apr 30, 2018 and Apr 29, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K091087); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING UMBILICAL HERNIA REPAIR, THE TWO NEEDLES WERE SEPARATING ON SUTURES. THE NEEDLE ALSO FELL INTO PATIENT'S CAVITY, BUT WAS RECOVERED BY GRASPING WITH NEEDLE HOLDER AND REMOVED VIA LAPAROSCOPIC PORT. A DEVICE FROM DIFFERENT MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750435 ↗
• InjuryApr 30, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A TOTAL LAPAROSCOPIC HYSTERECTOMY, PATIENTS DEVELOPED POSTOPERATIVE INFECTION/ CELLULITIS ON THEIR VAGINAL CUFF. DUE TO BENIGN DISEASES, EIGHTY-NINE PATIENTS WERE IN THE STANDARD SUTURE GROUP AND 208 PATIENTS WERE INCLUDED IN THE BARBED SUTURE GROUP. VAGINAL CUFF DEHISCENCE WAS IDENTIFIED IN ONLY THREE (3.3%) PATIENTS WITHIN THE STANDARD SUTURE GROUP AND NONE IN THE BARBED SUTURE GROUP. FIVE (5.6%) PATIENTS IN THE STANDARD SUTURE GROUP AND TWO (0.9%) PATIENTS IN THE BARBED SUTURE GROUP DEVELOPED POSTOPERATIVE CUFF INFECTION/CELLULITIS. DURATION OF THE SURGERY WAS SIGNIFICANTLY SHORTER IN THE BARBED SUTURE GROUP THAN IN THE STANDARD SUTURE GROUP. 180 UNIDIRECTIONAL BARBED SUTURE, WHICH WAS USED DURING SURGERY FOR VAGINAL CUFF CLOSURE, IS AN APPLICABLE, SAFE AND TOLERABLE ALTERNATIVE TO A STANDARD SUTURE. AT PRESENT, THERE WERE ONLY A LIMITED NUMBER OF STUDIES OF REGARDING THE SUTURE IN THE LITERATURE. WHAT THE RESULTS OF THIS STUDY DEMONSTRATED THAT BARBED SUTURES USED FOR ENABLING VAGINAL CUFF INTEGRITY DID NOT CAUSE MAJOR MORBIDITY AND MORTALITY FOR THE PATIENT. THEY SUGGESTED THAT THE BARBED SUTURES OFFER A PRACTICAL, SAFE AND TOLERABLE ALTERN

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 7472248 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.

• Z-2919-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0