V-Loc 90 VLOCM2044Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521132986), received between Aug 14, 2019 and Sep 6, 2023 — 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.

• MalfunctionSep 6, 2023Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC XI ROBOTIC ASSISTED INCARCERATED UMBILICAL HERNIA REPAIR WITH MESH, ONE HOUR AFTER OPENING FROM THE PACKAGE, THE THREAD BROKE DURING THE CLOSURE OF THE HERNIA SITE WHILE PERFORMING THE RUNNING SUTURE TECHNIQUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692477 ↗
• MalfunctionOct 28, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE DOING A RUNNING STITCH DURING A PACEMAKER IMPLANT, THE THREAD BROKE. THERE WERE THREE (3) DEVICES HAD THE SAME ISSUE OCCURRED ON SAME EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247963 ↗
• MalfunctionOct 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PACEMAKER IMPLANT, TOWARDS THE END OF THE PROCEDURE, WHEN THE DOCTOR THREW THE FIRST STITCH AND WHEN GOING THROUGH THE LOOP, THE SUTURE BROKE. PULLED ANOTHER SUTURE AND USED TO CLOSE THE POCKET. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192241 ↗
• MalfunctionAug 14, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGERY, IMPLANT OF THE PACEMAKER, AT THE END OF THE RUNNING STITCH, WHEN CLOSING THE INCISION, THE THREAD BROKE. THE DOCTOR LEFT AS IT IS TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892776 ↗

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