V-Loc VLOCN0644Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521134928), received between Feb 13, 2018 and Mar 3, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE AND THE NEEDLE WAS FRACTURED.

  Patient problems: Insufficient Information

  MAUDE report 24497040 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. 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 23688575 ↗
• MalfunctionSep 2, 2025Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE WAS DAMAGED WHEN WITHDRAWING FROM THE RETAINER AND PREPARING FOR SUTURING, BEFORE PATIENT USE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929957 ↗
• MalfunctionAug 1, 2025Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE PREPARING, AFTER OPENING THE PACKAGE, THE LOOP WAS DAMAGED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690526 ↗
• MalfunctionJul 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE WAS CUT THREE TIMES. SURGICAL TIME WAS EXTENDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563598 ↗
• MalfunctionApr 17, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIOPLASTY, AS THE SUTURE PASSED THROUGH THE TISSUE, THE NEEDLE BENT AND THE THREAD WAS CUT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857638 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT DURING SUTURING THE LOOP BECAME UNDONE, RENDERING THE DEVICE UNUSABLE.

  Patient problems: Insufficient Information

  MAUDE report 20912988 ↗
• MalfunctionMay 14, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE SUTURE WAS OVERLOCKED. THE THREAD DID NOT HOLD.

  Patient problems: Insufficient Information

  MAUDE report 19316225 ↗
• MalfunctionMay 14, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE SUTURE WAS OVERLOCKED. THE THREAD DID NOT HOLD.

  Patient problems: Insufficient Information

  MAUDE report 19316221 ↗
• MalfunctionJan 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE NEEDLE LOOSENED FROM THE THREAD INTO THE PATIENT'S A BDOMEN WITHOUT HAVING TO FORCE OR PULL ON THE THREAD. IT WAS LOCATED AND THE TWISTED INTRA-ABDOMINAL NEEDLE FOR EXTRACTION WAS RETRIEVED THROUGH THE 5MM TROCAR, AND THEN THE THREAD WAS RETRIEVED. ANOTHER SUTURE WAS ALSO OPENED TO RESOLVE THE ISSUE. THERE WAS NO PA TIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18457369 ↗
• MalfunctionOct 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE STOMACH, THE NEEDLE LOOSENED FROM THE THREAD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031360 ↗
• MalfunctionApr 21, 2023Break; Material Frayed; Detachment of Device or Device Component; Break; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, DURING CLOSURE OF THE INTESTINAL MEMBRANE, WHEN THE NEEDLE WAS ATTEMPTED TO PASS THROUGH THE LOOP OF SUTURE THREAD, THE LOOP BROKE. A PORTION OF LOOP PART OF SUTURE FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE PLACE WHERE THE LOOP WAS BELIEVED TO HAVE BEEN LOCATED GOT STOOP UP FRAYED, AND THE FRAYED AREA WAS ALSO DISCOVERED. IT WAS NOTED THAT NO DEVICE PIECES WAS LEFT IN THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785902 ↗
• MalfunctionSep 24, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE OF THE TWO DEVICES BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527179 ↗
• MalfunctionMar 8, 2021Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY PROCEDURE, WHEN THE CUSTOMER OPENED THE PACKAGE AND VISUALLY INSPECTING THE SUTURE, IT WAS FOUND THE LOOP OF SUTURE WAS MISSING, SO IT WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS CONTINUED. IN ADDITION THE THREAD DETACHED FROM THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436290 ↗
• MalfunctionJan 2, 2019Break; Break

  ACCORDING TO THE REPORTER, ON LAPAROSCOPIC GASTRIC BYPASS, IN THE BEGINNING OF THE CLOSURE USING CONTINUOUS SUTURING TECHNIQUE, THE SEAL OF THE ANCHORING LOOP CAME LOOSE AND THE DEVICE THEREFORE COULD NOT BE USED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209271 ↗
• MalfunctionMay 10, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING PETERSEN'S HERNIA PROCEDURE, IN THE BEGINNING OF THE CLOSURE, THE THREAD BROKE WHILE ON CONTINUOUS SUTURING. REPLACED BY A NEW THREAD TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503444 ↗
• MalfunctionMay 10, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PETERSEN'S HERNIA PROCEDURE, AT THE BEGINNING OF CLOSURE, THE THREAD BROKE WHILE THEY USED A CONTINUOUS SUTURING TECHNIQUE. THEY USED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503418 ↗
• MalfunctionMay 10, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PETERSEN'S HERNIA PROCEDURE, AT THE BEGINNING OF THE CLOSURE, THE THREAD BROKE WHILE THEY USED A CONTINUOUS SUTURING TECHNIQUE. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502943 ↗
• MalfunctionMay 10, 2018Break; Break

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE CLOSURE FOR LAPAROSCOPIC PETERSEN'S HERNIA PROCEDURE, THE THREAD OF THE DEVICE BROKE WHILE THEY USED A CONTINUOUS SUTURING TECHNIQUE. THEY USED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502873 ↗
• MalfunctionMay 10, 2018Break; Break

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF CLOSURE FOR A LAPAROSCOPIC PETERSEN'S HERNIA PROCEDURE, THE THREAD BROKE WHILE THEY USED A CONTINUOUS SUTURING TECHNIQUE. THEY USED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502872 ↗
• MalfunctionMar 19, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, JUST IN THE BEGINNING OF THE CLOSURE IN PETERSON'S HERNIA, THE SEAL OF THE WELDED LOOP CAME LOOSE, SO THE DEVICE COULD NOT BE ANCHORED. THEY USED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7349569 ↗
• MalfunctionMar 16, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, JUST IN THE BEGINNING OF THE CLOSURE IN PETERSON'S HERNIA, THE SEAL OF THE WELDED LOOP CAME LOOSE, SO THE DEVICE COULD NOT BE ANCHORED. THEY USED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7346247 ↗
• MalfunctionFeb 16, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE "SEAL" OF THE WELDED LOOP CAME LOOSE AND THEREFORE COULD NOT BE USED ANYMORE. 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 7278585 ↗
• MalfunctionFeb 13, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURES' LOOPS BROKE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7268233 ↗