V-Loc 90 VLOCM2004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521132976), received between Feb 5, 2025 and Feb 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 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.

• MalfunctionFeb 5, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC PROSTATECTOMY, THE NEEDLE BROKE RIGHT BEFORE THE SUTURE BEGINS. A PORTION OF THE NEEDLE WAS WITH THE SUTURE AND THE TWO THIRDS OF A NEEDLE ON THE OTHER.

  Patient problems: Insufficient Information

  MAUDE report 21313535 ↗
• MalfunctionFeb 5, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A ROBOTIC PROSTATECTOMY, THE NEEDLE BROKE RIGHT BEFORE THE SUTURE BEGINS. A PORTION OF THE NEEDLE WAS WITH THE SUTURE AND THE TWO THIRDS OF A NEEDLE ON THE OTHER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313023 ↗

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