V-Loc 90 VLOCM0223Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521132405), received between Nov 16, 2017 and May 13, 2019 — 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 13, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING AT THE END OF CAESARIAN SECTION PROCEDURE USING A STANDARD TECHNIQUE, THE STRAND OF THE SUTURE BROKE. THEY USED ANOTHER SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8606406 ↗
• MalfunctionMar 28, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL HYSTERECTOMY, AT THE END OF THE SKIN CLOSURE USING A SUB CUT CLOSURE, THE THREAD OF THE SUTURE BROKE. NEW SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460421 ↗
• MalfunctionAug 23, 2018Break; Break

  ACCORDING TO THE REPORTER, THE SUTURES LOOP AND THREAD BROKE WHILE CLOSING OFF THE SKIN DURING A CAESAREAN SECTION. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7809264 ↗
• MalfunctionNov 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING INTRAOPERATIVE PROCEDURE OF CESAREAN SECTION, NEEDLE WAS PUT THROUGH THE LOOP AS PER NORMAL, AS IT WAS PULLED THROUGH TO BEGIN A RUNNING SUTURE ALONG THE WOUND, THE THREAD SNAPPED JUST ABOVE THE LOOP. NEW SUTURE HAD TO BE OPENED, TO RESOLVE THE ISSUE AND TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038868 ↗

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