V-Loc 90 VLOCM0813Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521132702), received between Jul 21, 2017 and Apr 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING DERMAL SUTURING BEHIND THE EAR, THE LOOP OF THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022802 ↗
• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING TRANSANAL RESECTION OF A RECTAL MASS, THE DOCTOR WAS SUTURING THE RECTAL MUCOSA WHEN THE SUTURE SUDDENLY BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THIS SUTURE BREAKAGE AFFECTED HEMOSTASIS AT THE ANASTOMOSIS SITE AND IMPACTED THE PROGRESS OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23337445 ↗
• MalfunctionSep 21, 2018Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC PROCEDURE, THE DEVICE THREAD BROKE. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7897807 ↗
• MalfunctionAug 30, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, THE THREAD BROKE. THEY USED NEW PACKAGE OF SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7833885 ↗
• MalfunctionMay 21, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, WHILE THE SURGEON WAS PERFORMING A CONTINUOUS SUTURE, THE THREAD BROKE. THEY REPLACED TO A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529986 ↗
• MalfunctionMay 18, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE FIRST STEP OF THE SUTURE USING CONTINUOUS SUTURE TECHNIQUE IN A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, THE THREAD OF THE SUTURE BROKE. THEY OPENED A PACKAGE OF SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526387 ↗
• MalfunctionJul 21, 2017Break; Break

  ACCORDING TO THE REPORTER, AS PER THE ADDITIONAL INFORMATION RECEIVED, CURRENT STATUS OF THE PATIENT: STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6732531 ↗

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