V-Loc 90 VLOCM0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521131606), received between Sep 5, 2017 and Sep 30, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (16 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 24, 2026Class IIOpen, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2918-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that during a procedure, the suture loop was broken prior to handling after opening the package. The issue occurred on four sutures from the same batch. An additional new suture was used without issue as a replacement. The procedure was extended by not more than 30 minutes due to the product issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941591 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941509 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941176 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940939 ↗
• MalfunctionSep 29, 2026Break

  It was reported that during a procedure, the suture loop was broken prior to handling after opening the package. The issue occurred on four sutures from the same batch. An additional new suture was used without issue as a replacement. The procedure was extended by several minutes due to the product issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936139 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915015 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914855 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862922 ↗
• MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 2 SUTURES WERE OPENED, WHEN ONE WAS TAKEN OUT OF THE PACKAGE, THE THREAD BROKE OFF AT THE NEEDLE. THE OTHER PACKAGE WHEN THE DOCTOR STRAIGHTENED THE THREAD, IT BROKE OFF AT THE NEEDLE. IT WAS NOTED THAT THE STRENGTH OF THE SUTURE WAS POOR. ANOTHER SUTURE WAS USED WITHOUT ANY ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23089941 ↗
• MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 2 SUTURES WERE OPENED, WHEN ONE WAS TAKEN OUT OF THE PACKAGE, THE THREAD BROKE OFF AT THE NEEDLE. THE OTHER PACKAGE WHEN THE DOCTOR STRAIGHTENED THE THREAD, IT BROKE OFF AT THE NEEDLE. IT WAS NOTED THAT THE STRENGTH OF THE SUTURE WAS POOR. ANOTHER SUTURE WAS USED WITHOUT ANY ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23089772 ↗
• MalfunctionMar 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY PROCEDURE, BEFORE ENTERING THE PATIENT'S CAVITY, THE SUTURE STRAND BROKE OFF FROM THE NEEDLE WHEN GRABBED WITH THE SUTURE HOLDER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980243 ↗
• MalfunctionSep 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN BREAST RECONSTRUCTION, AT SKIN CLOSURE, THE THREAD BROKE. ANOTHER DEVICE 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 10532118 ↗
• MalfunctionJan 16, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE OF PACEMAKER POCKET, WHILE SUTURING OF POCKET AFTER PACEMAKER PLACED, IT WAS REPORTED THAT NEEDLE BROKE. THREAD ALSO 'BROKE' WHEN PULLING STRAND THROUGH TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253908 ↗
• MalfunctionJan 8, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING PACE MAKER PROCEDURE, LOOP BROKE WHEN NEEDLE WAS PULLED. SUTURE BROKE AGAIN WHEN ATTEMPTING TO TIE MANUALLY. ALTERNATIVE SUTURE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227498 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN PROCEDURE. THE NEEDLE DETACHED FROM THE SUTURE. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316204 ↗
• MalfunctionFeb 26, 2018Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE DURING SKIN CLOSURE, THE DEVICE'S THREAD BROKE. THE DEVICE HAS BEEN OPENED OR REMOVED FROM THE PACKAGING JUST BEFORE ITS USE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7296493 ↗
• MalfunctionFeb 26, 2018Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE DURING SKIN CLOSURE, THE DEVICE'S THREAD BROKE. THE DEVICE HAS BEEN OPENED OR REMOVED FROM THE PACKAGING JUST BEFORE ITS USE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7296266 ↗
• MalfunctionFeb 8, 2018Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, DURING SCALP EXCISION PROCEDURE, THE DEVICE THREAD BROKE DURING SKIN CLOSURE. NEW DEVICE WAS USED TO COMPLETE THE CASE. THE PHYSICIAN THREADED THE SUTURE THROUGH THE LOOP AND IT UNRAVELED WITHOUT ANY FORCE. THEY USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7251016 ↗
• MalfunctionOct 23, 2017Break; Break

  ACCORDING THE REPORTER, DURING SKIN CLOSURE INTRA-OPERATIVELY IN PARTIAL MASTECTOMY(OPEN PROCEDURE), WHEN THE SURGEON TOOK A BITE OF TISSUE AND PUT THE NEEDLE THROUGH THE LOOP AND THE LOOP END BROKE WHEN THE PRODUCT WAS TIGHTENED. IT WAS THE BEGINNING OF SUTURING PROCESS WHEN THE NEEDLE WAS PLACED THROUGH THE LOOP END EFFECTOR AND THE LOOP TORE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY NOTED DURING THIS EVENT. PATIENT STATUS : ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6969124 ↗
• MalfunctionSep 5, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC INCISION CLOSURE, THE DEVICE THREAD BROKE. THEY OPENED ANOTHER UNIT TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6842502 ↗