V-Loc 90 VLOCM0123Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521132238), received between Oct 19, 2017 and Jun 19, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN SUTURING THE PATIENT'S WOUND, THE FIRST STITCH CAUSED THE NEEDLE AND THREAD TO DETACHED AND IT COULD NOT BE USED. A NEW SUTURE WAS USED IMMEDIATELY TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289268 ↗
• MalfunctionJan 5, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING NORMAL SUTURING, THE SUTURE BROKE SEVERAL TIMES. THE SUTURE WAS CLEANED AND RETURNED TO THE MANUFACTURER. A NEW SUTURE WAS REPLACED FOR SUTURE. THE ISSUE PROLONGED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076565 ↗
• MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED INSTEAD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112353 ↗
• MalfunctionApr 24, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, SKIN CLOSURE, THE THREAD BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797415 ↗
• MalfunctionMar 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN PACKAGE WAS OPENED, THE NEEDLE AND THREAD SEPARATED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635611 ↗
• MalfunctionMar 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CESAREAN SECTION FOR SCAR UTERUS, THE INSTRUMENT WAS INTACT WHEN OPENED, BUT THE NEEDLE AND THREAD WERE FOUND TO BE SEPARATED WHEN USED. AFTER REPLACING THE DEVICE, THE SURGERY WAS NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591392 ↗
• MalfunctionMay 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN THYROIDECTOMY PROCEDURE, WHILE SUTURING THE SKIN, BOTH THE NEEDLE AND THREAD BROKE. THE SURGEON REOPENED A PACK FOR SUTURE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349563 ↗
• MalfunctionDec 22, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE PERFORMING SKIN CLOSURE, THE NEEDLE AND SUTURE WERE FOUND DETACHED WHEN THE PACKAGE WAS OPENED. THE SUTURE WAS BROKEN WHEN IT WAS TOUCHED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061837 ↗
• MalfunctionOct 23, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN THE DOCTOR WAS CLOSING THE SKIN DURING A CESAREAN PROCEDURE, THE THREAD BROKE. ANOTHER DEVICE WAS BROUGHT IN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7995029 ↗
• MalfunctionApr 13, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE DOING CONTINUOUS STITCHING, THE DEVICE BROKE. THERE WAS NO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428689 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE AND BEFORE IMPLANTATION, THE CUSTOMER NOTICED THAT THE LOOP OF THE PRODUCT CAME LO OSE AND BROKE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THIS ISSUE WAS NOTICED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316246 ↗
• MalfunctionJan 30, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A TBA PROCEDURE, WHILE BEING APPLIED FOR WOUND CLOSURE, WHEN THE DEVICE WAS OPENED, IT WAS FOUND THAT THE SUTURE DID NOT HAVE A LOOP ON THE END. THE AFFECTED PRODUCT WAS NOT REMOVED FROM PACKAGING. A SECOND SUTURE WAS OPENED AND WAS INTACT, AND WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228885 ↗
• MalfunctionJan 24, 2018Break; Device Packaging Compromised; Break; Device Packaging Compromised

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN OPENING THE PACKAGE THEY FOUND THAT THE LOOP AT THE END OF THE SUTURE HAD BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7216169 ↗
• MalfunctionJan 18, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE AND DID NOT HAVE A LOOP WHEN THE DEVICE WAS OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7203792 ↗
• MalfunctionNov 16, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN SECTION PROCEDURE. THE SUTURE WAS BEING USED FOR THE SKIN CLOSURE. THE LOOP OF THE SUTURE HAS GONE UP. THE THREAD OF THE SUTURE BROKE. OCCURRED ONE MINUTE INTO THE PROCEDURE. THE SUTURE WAS REMOVED FROM THE PACKAGING TWO MINUTES BEFORE USE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037113 ↗
• MalfunctionOct 19, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ¿SECTIO¿ PROCEDURE, THE SUTURE THREAD BROKE ONE MINUTE INTO THE SKIN CLOSURE. A NEW PRODUCT OF THE SAME LOT WAS USED TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6961390 ↗