V-Loc 90 VLOCM0316Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521132474), received between Nov 21, 2023 and Jul 24, 2025 — classified as 12 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K100257); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, ON THE UTERINE MUSCULAR LAYER AFTER REMOVAL OF UTERINE MYOMA, THE 2 DEVICES ABSORPTION WERE TOO FAST. IT WAS NOTED THAT A HEMATOMA OCCURRED AFTER THE OPERATION, SO IT WAS NOT POSSIBLE TO CULTIVATE THE ALVEOLI EVEN AFTER 1 YEAR.

  Patient problems: Hematoma

  MAUDE report 22585121 ↗
• MalfunctionJul 24, 2025Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER ON THE UTERINE MUSCULAR LAYER AFTER REMOVAL OF UTERINE MYOMA, THE 2 DEVICES ABSORPTION WERE TOO FAST. IT WAS NOTED THAT A HEMATOMA OCCURRED AFTER THE OPERATION, SO IT WAS NOT POSSIBLE TO CULTIVATE THE ALVEOLI EVEN AFTER 1 YEAR.

  Patient problems: Hematoma

  MAUDE report 22584916 ↗
• MalfunctionJul 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE DEVICE ABSORPTION WERE TOO FAST.

  Patient problems: Insufficient Information

  MAUDE report 22526802 ↗
• MalfunctionSep 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, DURING THE USE OF THE FIRST SUTURE, THE LOOP DETACHED AT THE MOMENT OF PASSING THE SUTURE. THE SECOND SUTURE PASSED, AND IT BURST AT THE MOMENT OF PASSING IT THROUGH THE TISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20285781 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEVEN SUTURE STRANDS BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304255 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEVEN SUTURE STRANDS BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304251 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEVEN SUTURE STRANDS BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304162 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEVEN SUTURE STRANDS BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304075 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEVEN SUTURE STRANDS BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304062 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEVEN SUTURE STRANDS BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304060 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEVEN SUTURE STRANDS BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304033 ↗
• MalfunctionNov 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN VAGINAL CUFF CLOSURE, THE THREAD BROKE VIA RUNNING SUTURING TECHNIQUE FOR THE TWO DIFFERENT SUTURES. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188002 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.

• Z-2918-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL