V-Loc 180 VLOCL0346Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521131057), received between Feb 19, 2018 and Aug 12, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217455 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122847 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE CAME APART WHERE IT ATTACHES TO THE STRAND. A 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 23406164 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THREE SUTURES FROM THE BATCH POPPED DURING A CLOSURE. A NEW SUTURE WAS USED, AND THE CLOSURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 22629105 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THREE SUTURES FROM THE BATCH POPPED DURING A CLOSURE. A NEW SUTURE WAS USED, AND THE CLOSURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 22629083 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THREE SUTURES FROM THE BATCH POPPED DURING A CLOSURE. A NEW SUTURE WAS USED, AND THE CLOSURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 22628941 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THREE SUTURES FROM THE BATCH POPPED DURING A CLOSURE. A NEW SUTURE WAS USED, AND THE CLOSURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 22628932 ↗
• MalfunctionFeb 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHEN CLOSING THE VAGINAL CUFF, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393608 ↗
• MalfunctionFeb 13, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, THERE WAS DIFFICULTY GETTING THROUGH THE CUFF WITH THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 21379370 ↗
• MalfunctionFeb 13, 2025Use of Device Problem; Dull, Blunt; Use of Device Problem; Dull, Blunt

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS DIFFICULTY GETTING THROUGH THE CUFF WITH THE SUTURE. THE SURGEON WAS ABLE TO PASS THE SUTURE THROUGH THREE TO FOUR TIMES BEFORE A REPRESENTATIVE WAS CALLED TO THE ROOM. UPON VISUAL INSPECTION VIA CAMERA, THE NEEDLE APPEARED QUITE ROUNDED OFF AT THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 21379288 ↗
• MalfunctionFeb 13, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, THERE WAS DIFFICULTY GETTING THROUGH THE CUFF WITH THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 21379070 ↗
• MalfunctionFeb 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE VAGINAL CUFF, THE SUTURE BROKE IN THE MIDDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349700 ↗
• MalfunctionFeb 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE VAGINAL CUFF, THE SUTURE BROKE IN THE MIDDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343419 ↗
• MalfunctionJan 9, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE SUTURE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117812 ↗
• MalfunctionDec 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROCEDURE INVOLVING AN XI ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL S ALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, AND CYSTOSCOPY, A NEEDLE DETACHMENT FROM THE SUTURE OCCURRED WHILE SUTURING/PREPARING THE SUTURE AFTER PATIENT INCISION. THE PROCEDURE WAS BEING PERFORMED TO CLOSE THE VAGINAL CUFF. THE DEVICE INVOLVED WAS THE 180 0 GRN 23CM GS21X12. THE PATIENT, A 68-YEAR-OLD INDIVIDUAL WITH A MEDICAL HISTORY OF AGE-RELATED OSTEOPOROSIS, DIABETES MELLITUS, HIGH CHOLESTEROL, HYPERTENSION, AND STAGE 3 CHRONIC KIDNEY DISEASE, WAS UNDERGOING THE PROCEDURE. THE NEEDLE DETACHMENT HAPPENED WHEN CINCHING DOWN THE SUTURE, BUT NOT OVERLY AGGRESSIVELY, AS NOTED BY THE SURGEON. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE OUTCOME FOR THE PATIENT WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 20924656 ↗
• MalfunctionDec 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, SENTINEL LYMPH NODE, AND CYSTOSCOPY PROCEDURE, THERE WERE TWO NEEDLE DETACHMENT WHILE CLOSING THE VAGINAL CUFF. THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE ISSUE WAS RESOLVED BY OPENING ANOTHER SUTURE OF THE SAME TYPE, BUT THE EXACT ISSUE OCCURRED AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917908 ↗
• MalfunctionDec 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, SENTINEL LYMPH NODE, AND CYSTOSCOPY PROCEDURE, THERE WERE TWO NEEDLE DETACHMENT WHILE CLOSING THE VAGINAL CUFF. THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE ISSUE WAS RESOLVED BY OPENING ANOTHER SUTURE OF THE SAME TYPE, BUT THE EXACT ISSUE OCCURRED AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917056 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC MYOMECTOMY, AT THE START OF THE PROCEDURE, THE SURGEON WAS GRABBING THE SUTURE STRAND AT THE SWAGE WITH THE ROBOTIC INSTRUMENT, THEN THE NEEDLE DETACHED FROM THE STRAND. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE FROM DIFFERENT BATCH. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064238 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC MYOMECTOMY, WHILE SUTURING, THE NEEDLE WAS DETACHED FROM THE STRAND. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057738 ↗
• MalfunctionApr 15, 2024Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING, THE THREAD BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105103 ↗
• InjuryFeb 27, 2024Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, FOLLOWING A RIGHT COLECTOMY WITH ANASTOMOSIS, THE PATIENT HAD AN UNPROTECTED SNEEZE AND INDICATED A POP INTERNALLY, AND IMAGING SHOWED A FACIAL DEHISCENCE WITH A SMALL BOWEL PROTRUSION. THE PATIENT RETURNED TO THE OPERATING ROOM FOR ABDOMINAL CLOSURE. THE SURGEON INDICATED THAT THE SUTURE BROKE, AND THE BREAK WAS NOT AT THE PLACE OF THE KNOT. THERE WAS NO INDICATION OF POOR SUTURING TECHNIQUE, THE TISSUE WAS NOT TORN BECAUSE OF THE DEHISCENCE. THERE WERE NO ISSUE AT ALL WITH THE SUTURE DURING THE INITIAL SURGERY.

  Patient problems: Unintended Radiation Exposure; Wound Dehiscence

  MAUDE report 18794745 ↗
• MalfunctionFeb 20, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC HYSTERECTOMY, THE THREAD OF TWO SUTURES BROKE DURING THE CLOSURE OF THE VAGINAL VAULT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738179 ↗
• MalfunctionFeb 13, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC HYSTERECTOMY, THE THREAD OF TWO SUTURES BROKE DURING THE CLOSURE OF THE VAGINAL VAULT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696415 ↗
• MalfunctionDec 1, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, AT CLOSURE OF THE VAGINAL VAULT, THE THREAD BROKE. COMPONENT DID NOT FALL INTO THE CAVITY A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250224 ↗
• MalfunctionSep 8, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE WAS SNAPPING. IT WAS NOT AS DURABLE AS THEY ARE.

  Patient problems: Insufficient Information

  MAUDE report 17716365 ↗

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