V-Loc 90 VLOCM0625Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521132634), received between Mar 27, 2018 and May 20, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A MASTOPEXY, ABDOMINOPLASTY AND THIGH LIPOSUCTION, DURING CLOSURE OF THE SUBCUTANEOUS LAYER, WHILE DOING A RUNNING STITCH, THE STRAND KINKED AND BROKE. THE THREAD GOT CAUGHT ON ITSELF AND THE FRICTION OF THE BARBS CAUSED IT TO BREAK. ANOTHER STRAND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14457528 ↗
• MalfunctionMay 18, 2022Break; Break

  ACCORDING TO THE REPORTER, WHEN SUTURING THE DEEP DERMAL LAYER DURING BREAST REDUCTION SURGERY, WHILE PERFORMING A RUNNING SUTURE TOWARDS THE END, TWO DEVICES THREAD BROKE. THE SURGEON OPENED ANOTHER PACK TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429290 ↗
• MalfunctionJan 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING OF THE PECTORALIS MAJOR, THE THREAD BREAKS OCCURRED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13306496 ↗
• MalfunctionMar 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE BEING APPLIED FOR THE SUTURING OF VAGINAL BLUNT, THE DEVICE¿S THREAD BROKE. SURGEON TRIED TO USE OTHER TWO SUTURES BUT HAD THE SAME ISSUE. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7373161 ↗

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