V-Loc 180 VLOCL0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521130401), received between Oct 30, 2017 and Apr 2, 2026 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (31 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-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY, WHEN THE SCRUB NURSE COUNTED THE SUTURE NEEDLES, IT WAS FOUND THAT THE NEEDLE AND SUTURE WERE DETACHED AND BROKEN. THE SUTURE WAS IMMEDIATELY REPLACED WITH A NEW ONE AND USE CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769457 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHILE SUTURING THE SUBCUTANEOUS, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645367 ↗
• MalfunctionMay 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A DERMAL BURIED SUTURE PROCEDURE, THE SUTURE BROKE WHILE SUTURING. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119726 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE REPLACEMENT PROCEDURE, A SUTURE WAS USED TO SUTURE THE JOINT CAPSULE AND SKIN; THE THREAD OF THE TWO SUTURES BROKE. THE SURGEON USED ANOTHER THREAD TO SUTURE AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371669 ↗
• MalfunctionMay 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, THE SUTURE WAS CUT WHEN TENSION WAS APPLIED DURING THE SUTURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353960 ↗
• MalfunctionApr 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ARTIFICIAL HIP JOINT REPLACEMENT, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154633 ↗
• MalfunctionApr 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ARTIFICIAL HIP JOINT REPLACEMENT, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154560 ↗
• MalfunctionApr 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ARTIFICIAL HIP JOINT REPLACEMENT, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153767 ↗
• InjuryApr 15, 2024Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVE A ARTIFICIAL HIP JOINT REPLACEMENT, A WOUND DISSECTION OCCURRED, REQUIRING ADDITIONAL SUTURE.

  Patient problems: Wound Dehiscence

  MAUDE report 19107032 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A WOUND OR SURGICAL INCISION CLOSURE AFTER CAESAREAN SECTION, WOUND DEHISCENCE OCCURRED WITH THE DERMAL SUTURE. THIS EVENT OCCURRED APPROXIMATELY ONE MONTH AFTER THE SURGERY. NO SUTURE BREAKAGE OCCURRED. LAPAROTOMY WAS PERFORMED. ABDOMEN WAS NOT OPENED, BUT ANOTHER DERMAL SUTURE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 17646670 ↗
• MalfunctionNov 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MAMMOPLASTY, AT THE TIME OF SKIN SUTURING, WHEN THE PACKAGE WAS OPENED, THE THREAD WAS DISENGAGED FROM THE NEEDLE. A NEW SUTURE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788860 ↗
• MalfunctionJul 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURE OPERATION, THE THREAD BROKE. ANOTHER SUTURE THREAD WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066073 ↗
• MalfunctionJun 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION PROCEDURE, WHILE CLOSING INCISION AND SUTURING DERMAL, THE NEEDLE GOT BROKE. A NEW PRODUCT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598634 ↗
• MalfunctionNov 19, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING THE INCISION DURING AN EXPLORATORY LAPAROSCOPY, THE SUTURE BROKE. THE USED ANOTHER SUTURE WITH THE SAME LOT NUMBER AND BROKE AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 12843141 ↗
• MalfunctionNov 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN ARTIFICIAL JOINT REPLACEMENT, WHEN THE SUTURE WAS OPENED, THE THREAD WAS BROKEN SO IT WAS NOT USED AND A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12764375 ↗
• MalfunctionSep 14, 2021Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN BREAST CANCER SURGERY, WHILE ON WOUND CLOSURE, THE SUTURE THREAD GOT EASILY BROKEN WHILE USING THE HORIZONTAL MATTRESS SUTURING TECHNIQUE. ANOTHER PRODUCT WAS USED AND OPENED TO COMPLETE THE PROCEDURE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468006 ↗
• MalfunctionJul 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ORTHOPEDIC SURGERY, THE THREAD CAME OFF FROM THE PROXIMAL END OF THE NEEDLE DURING THE STITCH. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207157 ↗
• MalfunctionJan 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A CAESAREAN PROCEDURE, DURING DERMAL SUTURING FOR INCISION CLOSURE, THE NEEDLE AND THREAD DISENGAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236450 ↗
• MalfunctionAug 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE THREAD OF THE SUTURE BROKE IMMEDIATELY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10406973 ↗
• MalfunctionJun 17, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE KEPT BREAKING OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165896 ↗
• MalfunctionFeb 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS OPENED DURING A PROCEDURE FOR ENDOSCOPIC CONTROL OF DUODENAL ULCER, THE NURSE ATTEMPTED TO HOLD THE NEEDLE WITH A NEEDLE HOLDER, BUT THE THREAD AND THE NEEDLE DISENGAGED. THE PRODUCT WAS NOT USED ON THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687287 ↗
• MalfunctionNov 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC LOWER ANTERIOR RESECTION, WHEN SUTURING WITH TRANSANAL MINIMALLY INVASIVE SURGERY (TAMIS), THE THREAD CAME OFF THE SWAGE. THE THREAD WAS CUT OFF AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9327573 ↗
• MalfunctionSep 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN EMERGENCY EXPLORATORY SURGERY, DURING THE 1ST SUTURING, THE THREAD DISENGAGED FROM THE NEEDLE WHILE LIFTING IT FROM THE PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9111409 ↗
• MalfunctionSep 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC COLECTOMY, WHILE SUTURING, THE DOCTOR HELD AND LIFTED THE THREAD WITH FORCEPS, HOWEVER THERE WAS NO NEEDLE AT THE TIP OF THE THREAD. IT WAS STATED THAT THE NEEDLE FELL INTO THE PATIENT¿S CAVITY AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9008125 ↗
• MalfunctionAug 22, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING A SURGICAL INCISION WITH SUTURE IN AN OPEN SURGERY, THE THREAD BROKE OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920823 ↗