V-Loc 180 VLOCL0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521130340), received between Dec 19, 2017 and Jul 25, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN OPENED FOR USE, THE THREAD AND NEEDLE OF THE SUTURE WERE DISCONNECTED FROM THE BEGINNING. ANOTHER SUTURE FROM THE SAME LOT WAS USED.

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

  MAUDE report 17390786 ↗
• MalfunctionJun 24, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION SURGERY, WHILE PERFORMING UTERINE CLOSING OF SURGICAL INCISION, THE THREAD WAS CUT DURING A CONTINUOUS SUTURE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806779 ↗
• MalfunctionAug 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVE TO SUBCUTANEOUS SUTURE, THE SWAGE OF THE NEEDLE AND THREAD CAME OFF AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333318 ↗
• MalfunctionMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO WOUND CLOSURE DURING DERMAL SUTURE OF SMALL INCISION, THE NEEDLE CAME OFF AT THE STAGE OF PULLING OUT THE NEEDLE THROUGH THE TISSUE ON THE FIRST STITCH. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775930 ↗
• MalfunctionMar 18, 2021Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL HERNIA REPAIR, THE SUTURE BROKE WHILE SUTURING. THE IN CISION SPLIT AND NEEDED TO BE SUTURED AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 11516108 ↗
• MalfunctionFeb 22, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE'S LOOP BROKEN. THEY USED ANOTHER 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 7288682 ↗
• MalfunctionFeb 5, 2018Break; Entrapment of Device; Break; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A THORACO-ESOPHAGUS PROCEDURE, WHILE CLOSING THE WOUND AND ON THE SECOND STITCH. THE LOOP BROKE AND THE THREAD GOT PULLED THROUGH THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7242246 ↗
• MalfunctionDec 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE. FOR TWO SUTURES, NEEDLE SEPARATION OCCURRED. THE NEEDLE CAM OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130530 ↗

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