V-Loc 180 VLOCL0326Recalls & reported problems

Summary

The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 10884521131002), received between Apr 25, 2017 and Sep 1, 2026 — classified as 15 injuries, 315 malfunctions.

The most frequently reported specific device problem is “Break” (186 reports).

1 other recall cover devices cleared under the same FDA submission (K091087); they may or may not involve this specific model.

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 330 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550070 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that preoperatively, the  needle detached from the suture while being removed from the retainer. An additional new suture was used without issue. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484069 ↗
• MalfunctionAug 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419681 ↗
• MalfunctionAug 10, 2026Detachment of Device or Device Component

  According to the reporter, during a laparoscopic uterine mass enucleation due to uterine leiomyoma, after the mass had been removed, the first stitch was placed and when the needle was exiting the tissue, the tail of the needle separated from the suture resulting in uterine bleeding. A new suture was used to resolve the issue.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50201133 ↗
• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065772 ↗
• MalfunctionJul 7, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, NEEDLE-SUTURE SEPARATION OCCURRED IN TWO CONSECUTIVE SUTURES WHILE SUTU RING. ANOTHER BRAND OF SUTURE WAS THEN USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742765 ↗
• MalfunctionJul 7, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, NEEDLE-SUTURE SEPARATION OCCURRED IN TWO CONSECUTIVE SUTURES WHILE SUTURING. ANOTHER BRAND OF SUTURE WAS THEN USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742760 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MYOMECTOMY, THE NEEDLE-SUTURE SEPARATION OCCURRED IMMEDIATELY UPON REMOVING THE ITEM FROM ITS PACKAGING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353596 ↗
• MalfunctionMay 20, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC MYOMECTOMY, WHILE IN THE UTERUS, AFTER SEVERAL STITCHES, THE NEEDLE AND SUTURE DETACHED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226017 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING A MYOMECTOMY, THE ABSORBABLE SUTURE BROKE WHILE SUTURING THE UTERINE SEROMUSCULAR LAYER. A NEW ABSORBABLE SUTURE WAS IMMEDIATELY REPLACED, AND SUTURING WAS CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25005395 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A LUMBAR SPINE SURGERY, USING THE ABSORBABLE SUTURE VIA THE CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE A FEW MINUTES INTO THE PROCEDURE. AN ADDITIONAL NEW SUTURE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958718 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR A PATIENT WITH AN OVARIAN TUMOR, IN CLOSING THE VAGINAL CUFF, AFTER PLACEMENT OF THE FIRST STITCH, THE SUTURE BROKE DURING TRACTION. THIS INCREASED THE DIFFICULTY OF THE PROCEDURE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945636 ↗
• MalfunctionApr 10, 2026Break

  ACCORDING TO THE REPORTER, DURING SURGICAL SUTURING, THE SUTURE BROKE WITH GENTLE TRACTION. AFTER KNOTTING, THE SURGERY WAS CONTINUED. THE EVENT LED TO EXTENDED SURGICAL TIME BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841821 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL UTERINE FIBROID REMOVAL SURGERY, WHILE UNBOXING, THE SUTURE EXHIBITED TAIL RING CRACKING. AN ADDITIONAL NEW SUTURE OF THE SAME PRODUCT ID AND LOT NUMBER WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707645 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE OF THE SUTURE. 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 24694608 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRAOPERATIVELY, WHILE SUTURING, THE NEEDLE DISCONNECTED FROM THE THREAD. 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 24690072 ↗
• MalfunctionMar 23, 2026Break

  ACCORDING TO THE REPORTER, DURING THE JOINT KNEE REPLACEMENT, THE THREAD BROKE IMMEDIATELY WHEN USING CONTINUOUS SUTURING TECHNIQUE. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24668258 ↗
• InjuryMar 6, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE NEEDLE HAD POOR RIGIDITY, CAUSING IT TO DEFORM, BREAK EASILY, AND REMAIN IN THE ABDOMINAL CAVITY, MAKING IT DIFFICULT TO RETRIEVE. THE SUTURE WAS IMMEDIATELY REPLACED HOWEVER, THE SAME ISSUE RECURRED WITH THE REPLACEMENT DEVICE, LEADING TO DELAYED SURGICAL CLOSURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24532886 ↗
• InjuryMar 6, 2026Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE NEEDLE HAD POOR RIGIDITY, CAUSING IT TO DEFORM, BREAK EASILY, AND REMAIN IN THE ABDOMINAL CAVITY, MAKING IT DIFFICULT TO RETRIEVE. THE SUTURE WAS IMMEDIATELY REPLACED; HOWEVER, THE SAME ISSUE RECURRED WITH THE REPLACEMENT DEVICE, LEADING TO DELAYED SURGICAL CLOSURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24532798 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE LOOP BROKE WHILE SUTURING. THE SUTURE WAS REPLACED WITH A COMPETITOR'S PRODUCT TO RESOLVE THE ISSUE.

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

  MAUDE report 24449501 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRE-OPERATIVELY, TWO SUTURES HAD NEEDLE AND THREAD DETACHMENT WHILE BEING REMOVED FROM ITS PACKAGING. AN ADDITIONAL NEW SUTURE, NOT OF THE SAME PRODUCT ID AND LOT NUMBER, WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447442 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRE-OPERATIVELY, TWO SUTURES HAD NEEDLE AND THREAD DETACHMENT WHILE BEING REMOVED FROM ITS PACKAGING. AN ADDITIONAL NEW SUTURE, NOT OF THE SAME PRODUCT ID AND LOT NUMBER, WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447380 ↗
• MalfunctionFeb 25, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE AFTER COMPLETING JUST ONE STITCH, AFFECTING THE PROGRESS OF THE OPERATION. A NEW SUTURE WAS USED TO RE-SUTURE THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447293 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A UTERINE FIBROID (GYNECOLOGY) PROCEDURE, THE NEEDLE AND THREAD WERE DETACHED WHEN PREPARING FOR SUTURING. THE DEVICE WAS PROMPTLY REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201882 ↗
• MalfunctionJan 27, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UTERINE FIBROID REMOVAL SURGERY, WHILE SUTURING THE UTERUS, AFTER ONE STITCH, BOTH NEEDLE AND THREAD 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 24189604 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.

• Z-2919-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0