V-Loc 180 VLOCL0814Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521131323), received between Aug 15, 2017 and Sep 21, 2026 — classified as 2 injuries, 14 malfunctions.

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

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848038 ↗
• MalfunctionAug 18, 2026Break

  It was reported that preoperatively, the three sutures loop were broken. Another product was replaced to resolve the issue. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311249 ↗
• MalfunctionJul 6, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A TOTAL HYSTERECTOMY WITH BILATERAL ADNEXECTOMY, WHILE SUTURING WITH AN ABSORBABLE SUTURE, THE NEEDLE AND THREAD SEPARATED. THE ISSUE DELAYED THE PROGRESS OF THE SURGERY AND INCREASED THE OPERATION TIME.

  Patient problems: Insufficient Information

  MAUDE report 25718941 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY, THE SUTURE LOOP BROKE PRIOR TO HANDLING AFTER OPENING THE PACKAGE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512320 ↗
• MalfunctionJun 24, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SKIN INCISION WAS SUTURED, THE SUTURE SUDDENLY BROKE. THE DEVICE COULD NO LONGER BE USED. THE ISSUE ALSO LED TO THE OPENING OF THE WOUND. A NEW SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 19595905 ↗
• MalfunctionJan 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CERVICAL SPINE SURGERY, THE CONNECTION BETWEEN THE TAIL LOOP AND THE SUTURE BODY HAS COME OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531812 ↗
• MalfunctionNov 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PROCEDURE, THE NEEDLE AND THE THREAD OF ONE SUTURE WERE FOUND TO BE DISENGAGED DURING REMOVAL FROM THE PACKAGE. ANOTHER SUTURE¿S THREAD BROKE HALFWAY IN THE MULTIPLE SUTURING IN ANASTOMOSIS SCENE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12730487 ↗
• MalfunctionAug 31, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PACEMAKER PLACEMENT, AT SUTURE CLOSURE OF SUBCUTANEOUS TISSUE, THE NEEDLE AND THREAD CAME OFF. THE LOOP WAS ALSO MISSING FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12398308 ↗
• MalfunctionJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DERMIS SUTURING FOR A CAESAREAN SECTION, WHEN THE DOCTOR TRIED TO ATTACH A THREAD TO THE NEEDLE, THE THREAD WAS REMOVED FROM THE NEEDLE AND COULD NOT BE USED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037516 ↗
• MalfunctionNov 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A TRANSABDOMINAL PREPERITONEAL, THE SUTURE AND THE NEEDLE WERE FOUND DETACHED WHEN UN PACKING. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10800117 ↗
• InjurySep 19, 2018Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE LOOP UNRAVELED, THERE WAS A RISK OF INFECTION DUE TO REOPENING THE INCISION WHICH EXTENDED THE SURGICAL TIME. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7891498 ↗
• InjurySep 11, 2018Material Erosion; Material Erosion

  ACCORDING TO THE REPORTER, 12 DAYS FOLLOWING AN INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT UNDERWENT AN EMERGENCY OPERATION DUE TO BLOCKAGE. THE PERITONEAL STITCHES FROM THE SUTURE USED ON THE ORIGINAL PROCEDURE HAD INTERNALIZED IN THE SMALL INTESTINE CREATING A VOLVULUS AND BLOCKAGE.

  Patient problems: No Code Available; Obstruction/Occlusion

  MAUDE report 7864715 ↗
• MalfunctionAug 9, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY PROCEDURE, WHEN THE SURGEON WAS CLOSING THE PERITONEUM, THE THREAD BROKE, THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7768542 ↗
• MalfunctionOct 24, 2017Break; Break

  ACCORDING TO THE REPORTER, PER ADDITIONAL INFORMATION RECEIVED DURING A CESAREAN SECTION, WHEN THE PACKAGE WAS OPENED IT WAS NOTICED THAT THE LOOP WAS BROKEN AND NOT DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6973870 ↗
• MalfunctionSep 15, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A CESAREAN SECTION. DURING SUTURING, THE LOOP BROKE. THERE WAS NOT EXCESSIVE FORCE ON THE LOOP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868539 ↗
• MalfunctionAug 15, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE DERMAL SUTURING, WHEN THE FIRST STITCH WAS MADE AND THE NEEDLE GOT THROUGH THE LOOP, THE LOOP BROKE ALTHOUGH NO FORCE WAS ADDED ,AND THE THREAD CAME THROUGH OUT. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6793832 ↗

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