V-Loc VLOCN0327Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20884521127903), received between May 6, 2016 and Aug 10, 2026 — classified as 4 injuries, 23 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192670 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, WHILE SUTURING, AFTER PASSAGE OF THE NEEDLE THROUGH THE LOOP AND FIXING IT AT THE START POINT, THE LOOP BROKE. THE SUTURE WAS REMOVED AND A COMPETITOR BARBED SUTURE WAS USED TO CONTINUE. THEREWAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072274 ↗
• MalfunctionMar 30, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, ON THE ABDOMINAL WALL, THE SUTURE BROKE IN THE MIDDLE. ANOTHER NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722674 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ABDOMINAL HYSTERECTOMY, THE NEEDLE DETACHED FROM THE SUTURE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. AN ADDITIONAL 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 24167731 ↗
• MalfunctionOct 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN ABDOMINOPLASTY PROCEDURE, IN THE INITIAL STAGE, THE SUTURE THREAD RUPTURED AND HAD TO BE REPLACED BEFORE CONTINUING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408671 ↗
• MalfunctionOct 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN ABDOMINOPLASTY, AT THE TIME OF ABDOMEN SUTURING, THE LOOP OF THE SUTURE WAS BROKEN. ANOTHER SUTURE WITH THE SAME LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354266 ↗
• InjurySep 15, 2025Break; Patient-Device Incompatibility; Break; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER AFTER THE PROCEDURE, THE SUTURE THREAD BROKE AND IT WAS NECESSARY TO REINTERVENE ON THE PATIENT.

  Patient problems: Foreign Body Reaction; Insufficient Information; Tissue Breakdown

  MAUDE report 23050830 ↗
• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EXTENDED TOTALLY EXTRAPERITONEAL ETEP METHOD FOR ABDOMINAL WALL INCISIONAL HERNIA REPAIR, THE NEEDLE DETACHED AND DISENGAGED. TO RESOLVE THE ISSUE, THE NEEDLE WAS RETRIEVED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148133 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL INCISIONAL HERNIA PROCEDURE, THE SUTURE USED FOR HERNIA GATE CLOSURE BROKE. ANOTHER SUTURE WAS USED, BUT THE NEEDLE DETACHED AND FELL INTO THE PATIENT'S CAVITY WHILE SUTURING. THE NEEDLE WAS CONFIRMED BY THE CAMERA AND WAS SUCCESSFULLY RETRIEVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297265 ↗
• MalfunctionSep 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL INCISIONAL HERNIA PROCEDURE, THE SUTURE USED FOR HERNIA GATE CLOSURE BROKE. ANOTHER SUTURE WAS USED, BUT THE NEEDLE DETACHED AND FELL INTO THE PATIENT'S CAVITY WHILE SUTURING. THE NEEDLE WAS CONFIRMED BY THE CAMERA AND WAS SUCCESSFULLY RETRIEVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296308 ↗
• MalfunctionSep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION MYOMETRIAL SUTURE, THE NURSE MISTAKENLY USED A SIZE 1 45CM BARBED SUTURE INSTEAD OF A 90-DAY ABSORBABLE BARBED SUTURE. THE MEDICAL STAFF HAD TO CUT THE SUTURE USING A HYSTEROSCOPE.

  Patient problems: Insufficient Information

  MAUDE report 20256417 ↗
• InjurySep 11, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING INFERTILITY TREATMENT, A SUTURE WAS FOUND EXPOSED WITHIN THE UTERINE LUMEN/CAVITY, WHICH WAS THEN RESECTED AND REMOVED USING SCISSORS. TO RESOLVE THE ISSUE, REMOVAL OF THE EXPOSED SUTURES WAS PERFORMED IN THE UTERINE CAVITY VIA HYSTEROSCOPY.

  Patient problems: Tissue Breakdown

  MAUDE report 20195120 ↗
• MalfunctionJun 7, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA, WHEN THE TIME OF HERNIA GATE CLOSURE BY IPOM (INTRAPERITONEAL ONLAY MESH), WHEN ATTEMPTED TO SUTURE THE PERITONEUM, THE THREAD BROKE WHEN THE NEEDLE PASSED THROUGH THE LOOP. USED ANOTHER PACKAGE WITH THE SAME LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079256 ↗
• MalfunctionApr 19, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL PLICATION OR TUMMY TUCK PROCEDURE, WHILE PERFORMING THE RUNNING STITCH TECHNIQUE, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16772802 ↗
• MalfunctionApr 18, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SUTURE SNAPPED IN THE MIDDLE OF THE STRAND AS IT WAS BEING PULLED OUT OF THE PACKAGING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765386 ↗
• MalfunctionApr 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE SUTURE WAS APPLIED TO CLOSE THE PERITONEUM FLAP, THE NEEDLE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674633 ↗
• InjuryFeb 23, 2023Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 1 DAY POST-OPERATIVE OF A LAPAROSCOPIC ABDOMINAL WALL INCISIONAL HERNIA, WHERE THE DEVICE WAS USED FOR FASCIAL CLOSURE, THE SUTURE RUPTURED AND THE PATIENT HAD WOUND DEHISCENCE. THERE WAS UMBILICAL SUTURE SEPARATION WHICH CAUSED TISSUE DAMAGE/LOSS. REPEAT SURGERY WAS PERFORMED THE NEXT DAY TO CLOSE THE ABDOMINAL WALL.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16428077 ↗
• MalfunctionJul 28, 2022Break; Break

  ACCORDING TO THE REPORTER, 45 MINUTES INTO AN OPEN ABDOMINOPLASTY, WHILE EMPLOYING THE RUNNING SUTURE TECHNIQUE DURING MUSCLE PLICATION, THE THREAD BROKE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122226 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, IT WAS OUT OF BOX FAILURE WHEN THE FOIL WAS OPENED, NEEDLE AND THREAD WAS NOT ATTACHED. THE DEVICE WAS NOT USED TO THE PATIENT. A NEW SUTURE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15104904 ↗
• MalfunctionNov 12, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, AT THE TIME OF THE FACIAL CLOSURE, THE SUTURE BROKE. BECAUSE FIVE OUT OF 12 SUTURES IN A BOX CRACKED, THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES TO TAKE A NEW SUTURE THAT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10828116 ↗
• MalfunctionJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TISSUE CLOSURE OF A LAPAROSCOPIC HERNIA REPAIR, THREE HOURS INTO THE PROCEDURE, BOTH NEEDLE AND THREAD OF THREE SUTURES BROKE. A NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED BY THE SURGEON DURING THE SURGERY. THE PATIENT EXPERIENCE PAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; Pain

  MAUDE report 10250807 ↗
• MalfunctionMar 7, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE SUTURING THE SLEEVE USING A STANDARD RUNNING STITCH, THE DEVICES¿ THREAD BROKE, WHEREIN THE STRANDS WERE BREAKING. IN ORDER TO RESOLVE THE ISSUE, A NEW STRAND WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7320709 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE SUTURING THE SLEEVE USING A STANDARD RUNNING STITCH, THE DEVICES¿ THREAD BROKE, WHEREIN THE STRANDS WERE BREAKING. IN ORDER TO RESOLVE THE ISSUE, A NEW STRAND WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318639 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE SUTURING THE SLEEVE USING A STANDARD RUNNING STITCH, THE DEVICES¿ THREAD BROKE, WHEREIN THE STRANDS WERE BREAKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318627 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER: THE STRAND OF THE SUTURE BROKE AT THE LOOP WHICH HOLDS THE SUTURE IN PLACE. OCCURRED WHEN ANCHORING THE SUTURE DOWN. FOUR SUTURES WITH THE SAME LOT NUMBER WERE OPENED WITH TWO BREAKING. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER SUTURE OF THE SAME TYPE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. CURRENT PATIENT STATUS IS WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316173 ↗