V-Loc 180 VLOCL0804Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10884521131286), received between Jul 25, 2017 and Aug 27, 2026 — classified as 13 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (71 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 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  According to the reporter, during the procedure, it was discovered that there was no loop when the needle was inserted into the abdominal cavity because the loop had broken. A new suture was opened and used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479938 ↗
• MalfunctionJun 10, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457587 ↗
• MalfunctionMar 9, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN PULLING OUT FROM THE RETAINER AND PREPARING FOR SUTURING, THE NEEDLE WAS DETACHED. A NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552514 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD CAME LOOSE FROM THE NEEDLE, MAKING ITS USE IMPOSSIBLE, AND IT WAS NECESSARY TO OPEN A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344895 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A DIFFICULTY IN REMOVING THE SUTURE FROM THE RETAINER OR PACKAGING AND THE THREAD WAS TORN OUT OF THE NEEDLE'S REINFORCEMENT ZONE. THE ISSUE OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND FIVE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309295 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A DIFFICULTY IN REMOVING THE SUTURE FROM THE RETAINER OR PACKAGING AND THE THREAD WAS TORN OUT OF THE NEEDLE'S REINFORCEMENT ZONE. THE ISSUE OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND FIVE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309286 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A DIFFICULTY IN REMOVING THE SUTURE FROM THE RETAINER OR PACKAGING AND THE THREAD WAS TORN OUT OF THE NEEDLE'S REINFORCEMENT ZONE. THE ISSUE OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND FIVE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309267 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A DIFFICULTY IN REMOVING THE SUTURE FROM THE RETAINER OR PACKAGING AND THE THREAD WAS TORN OUT OF THE NEEDLE'S REINFORCEMENT ZONE. THE ISSUE OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND FIVE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309253 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A DIFFICULTY IN REMOVING THE SUTURE FROM THE RETAINER OR PACKAGING AND THE THREAD WAS TORN OUT OF THE NEEDLE'S REINFORCEMENT ZONE. THE ISSUE OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND FIVE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309250 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING SUTURING, THE BARBED SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219138 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE CAME LOOSE DURING A VESICOURETHRAL ANASTOMOSIS, THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23851722 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROSTATECTOMY WITH ROBOT SUPPORT, WHEN PULLING IT OUT FROM THE RETAINER AND PREPARING FOR SUTURING (BEFORE USE ON THE PATIENT), THE NEEDLE WAS DETACHED. A NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701616 ↗
• MalfunctionOct 30, 2025Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IT WAS NOTED THAT THE NEEDLE WAS NOT ATTACHED; THE NEEDLE DID NOT EXIST.

  Patient problems: Insufficient Information

  MAUDE report 23430124 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A RADICAL PROSTATECTOMY WITH ROBOT SUPPORT, DURING VESICOURETHRAL ANASTOMOSIS, THE NEEDLE DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913997 ↗
• MalfunctionAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUTURE THREAD WAS DISCONNECTED FROM THE NEEDLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833590 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE ROBOTIC LAPAROSCOPIC PROSTATECTOMY, WHILE ON ANASTOMOSIS, NEEDLE DETACHMENT OCCURRED FOR THE TWO SUTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079950 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE ROBOTIC LAPAROSCOPIC PROSTATECTOMY, WHILE ON ANASTOMOSIS, NEEDLE DETACHMENT OCCURRED FOR THE TWO SUTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079897 ↗
• MalfunctionApr 23, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY, WHILE SUTURING THE BLADDER AND URETER, A MINUTE AFTER, THE THREAD BROKE. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892529 ↗
• MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PARTIAL NEPHRECTOMY WITH ROBOT SUPPORT, WHILE SUTURING AFTER PARTIAL KIDNEY RESECTION THE NEEDLE DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415622 ↗
• MalfunctionDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROSTATECTOMY, WHILE SUTURING, THE NEEDLE DETACHED FROM 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 20855541 ↗
• MalfunctionNov 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL GASTRIC CANCER SURGERY, AT THE TIME OF GASTROINTESTINAL SUTURING VIA CONTINUOUS SUTURE TECHNIQUE, THE THREAD BROKE. IT OCCURRED ON DIFFERENT TWO SUTURES. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668710 ↗
• MalfunctionOct 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE ORTHOPEDIC TOTAL HIP ARTHROPLASTY, WHEN SUTURING THE SUBCUTANEOUS DERMIS OF THE THIGH REGION, THE SUTURE BROKE ON THE CENTER REGION. ANOTHER NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526349 ↗
• MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD CAME LOOSE FROM THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455298 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS SUTURE DETACHMENT UPON NEEDLE INTRODUCTION. IT WAS NOTED THAT NO NEEDLE FELL IN THE PATIENT CAVITY. THERE WAS LOSS OF TIME DURING THE OPERATION. AN ADDITIONAL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443409 ↗
• MalfunctionOct 2, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC CANCER RADICAL SURGERY, ANASTOMOTIC REINFORCEMENT, THE THREAD WAS BROKEN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352035 ↗