V-Loc 90 VLOCM0814Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521132719), received between Jan 8, 2020 and Nov 7, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROSTATECTOMY SURGERY WITH A DAVINCI ROBOT, A 1MM NEEDLE POINT BROKE OFF FROM THE NEEDLE WHILE SUTURING AND WAS RETAINED IN THE PERIURETAL TISSUE. THE NEEDLE POINT WAS NOT RETRIEVED DUE TO CONTINENCE CONSIDERATIONS. A COMPUTED TOMOGRAPHY EXAMINATION OF THE PELVIS WAS PERFORMED ONE DAY AFTER SURGERY FOR FORENSIC REASONS, AND THE FOREIGN BODY (NEEDLE POINT) WAS VISUALIZED ON IMAGING. PATIENT LEFT THE HOSPITAL AND WENT HOME WITHOUT ANY SYMPTOMS.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 23501627 ↗
• MalfunctionNov 1, 2021Break; Break

  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 12730902 ↗
• MalfunctionJan 8, 2020Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE ON A BLADDER, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 9563485 ↗

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