V-Loc 90 VLOCM1545Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521132832), received between Apr 5, 2021 and Oct 10, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING VAGINAL VAULT CLOSURE, WHILE USING THE SUTURE, THE SUTURE SNAPPED. THE SURGEON STATED THIS WAS NOT DURING EXCESSIVE FORCE OF THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418494 ↗
• MalfunctionFeb 23, 2023Component Missing; Component Missing

  ACCORDING TO THE REPORTER, WHEN THE FOIL WAS OPENED, THERE WAS NO SUTURE IN THE PACKET.

  Patient problems: Insufficient Information

  MAUDE report 16430948 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, WHILE USING THE ABSORBABLE WOUND CLOSURE DEVICE TO SEW UP VAGINAL VAULT, THE SUTURE BROKE MIDWAY THROUGH SUTURING. THE SURGEON NOR THE ASSISTANT WERE HOLDING THE SUTURE AT THE SITE OF BREAK. NEW SUTURE WAS OBTAINED TO CLOSE REMAINDER OF VAGINAL VAULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718686 ↗
• MalfunctionJun 13, 2022Break; Break

  ACCORDING TO THE REPORTER, ON A ROBOTIC LAPAROSCOPIC PROCEDURE, WHILE EMPLOYING THE RUNNING STITCH TECHNIQUE, THE THREAD OF 5 SUTURES EASILY BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675724 ↗
• MalfunctionApr 5, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, WHEN SUTURING THE VAGINAL WALL, THE NEEDLE BROKE TWICE. THE SURGEON RESTARTED SUTURING AND USED ANOTHER NEEDLE WHICH RESULTED TO SURGICAL EXTENSION BY 10 MINUTES AND OVER-CONSUMPTION OF PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613432 ↗

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