V-Loc 90 VLOCM0305Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521132436), received between Aug 9, 2017 and Dec 12, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K100257); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, WHEN SUTURING OF THE VAGINAL VAULT, THE NEEDLE BROKE. THE BROKEN PIECES WERE REMOVED, AND A NEW SUTURE WAS USED TO COMPLETE THE CLOSURE WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795906 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE SUTURING THE VAULT OF THE VAGINA, THE SUTURE STRAND BROKE IN THE MIDDLE DURING THE PROCEDURE. 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 22373936 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, WHILE REMOVING FROM THE RETAINER THE NEEDLE WAS DETACHED. IT WAS ALSO NOTED THAT THE NEEDLE CAME OFF THE SUTURE WHILE BEING PASSED THROUGH THE PORT TO BE USED. THE NEEDLE WAS LOCATED INSIDE THE PORT, RETRIEVED AND A NEW BARBED SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22270453 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAULT OF THE VAGINA, THE SUTURE STRAND SNAPPED IN THE MIDDLE, AFFECTING TWO SUTURES FROM THE SAME BATCH. A THIRD SUTURE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995172 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAULT OF THE VAGINA, THE SUTURE STRAND SNAPPED IN THE MIDDLE, AFFECTING TWO SUTURES FROM THE SAME BATCH. A THIRD SUTURE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995074 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, AT THE TIME TO SEW THE VAGINAL CUFF AND REMOVING THE SUTURE FROM THE PORT, THE NEEDLE DETACHED FROM THE SUTURE AND FELL INTO THE CAVITY. IT WAS NOTED THAT THERE WAS NO RESISTANCE BUT JUST THAT THE NEEDLE FELL OFF. IT WAS RETRIEVED SUCCESSFULLY WITH THE INSTRUMENT. IT OCCURRED ON TWO SUTURES. ANOTHER SUTURE BUT IN 9 INCHES LENGTH WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571055 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, AT THE TIME TO SEW THE VAGINAL CUFF AND REMOVING THE SUTURE FROM THE PORT, THE NEEDLE DETACHED FROM THE SUTURE AND FELL INTO THE CAVITY. IT WAS NOTED THAT THERE WAS NO RESISTANCE BUT JUST THAT THE NEEDLE FELL OFF. IT WAS RETRIEVED SUCCESSFULLY WITH THE INSTRUMENT. IT OCCURRED ON TWO SUTURES. ANOTHER SUTURE BUT IN NINE INCHES LENGTH WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553809 ↗
• MalfunctionSep 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ALL THREE SUTURES HAD THEIR STRAND BROKEN WHILE BEING USED ON A CONTINUOUS SUTURING.

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

  MAUDE report 17846229 ↗
• MalfunctionAug 18, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, WHILE THE SUTURE WAS USED TO CLOSE MYOMETRIUM AFTER MYOMA EXCISION, THE SUTURE WAS ALREADY IN THE PATIENT THAT DID NOT HOLD AS THEY ARE SUPPOSED TO, AND ONLY GAVE WAY FOR ONE DAY AFTER PROCEDURE. THE SUTURE WAS REMOVED AND REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250902 ↗
• InjuryMay 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HYSTERECTOMY, THE NEEDLE DETACHED FROM THE THREAD AND THE SURGEON WAS NOT ABLE TO FIND THE NEEDLE BOTH INSIDE THE PATIENT AND IN THE OPERATING ROOM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14270411 ↗
• InjuryFeb 13, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 23 DAYS POST-OPERATIVELY OF A LAPAROSCOPIC ABDOMINAL WALL HERNIA REPAIR, THE MESH HAD NOT FUSED WITH PERITONEUM. A PART OF TACKING CAME OFF AND WAS FOUND HANGING IN THE ABDOMINAL CAVITY. ON THE RIGHT SIDE, THE MESH WAS FOUND TO HAVE A GAP BETWEEN THE MESH AND PERITONEUM. THE THREAD FOR THE PLICATED HERNIA ORIFICE WAS ALSO IN THE CONDITION THAT HAD COME OFF. REPAIR FOR THE RELAPSE WAS DONE. A SMALL LAPAROTOMY WITH ANOTHER MESH WAS PERFORMED TO REPAIR THE RELAPSE.

  Patient problems: No Code Available

  MAUDE report 9708382 ↗
• MalfunctionSep 5, 2019Break; Break

  ACCORDING TO THE REPORTER, NOT LONG AFTER THE REMOVAL OF THE DEVICE FROM THE PACKET DURING PREPARATION, THE THREAD BROKE. IT WAS STATED THAT THAT 3 SUTURES FROM DIFFERENT LOT NUMBERS HAD THE ISSUE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8967889 ↗
• MalfunctionAug 7, 2018Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER ONE STITCH WITH A NEEDLE HOLDER, THE THREAD WAS DETACHED. TWO PACKS OF THE PRODUCT HAD THE SAME ISSUE. AFTER THE ISSUE, A SAME SIZE OF THE THREAD WAS USED AND COMPLETED THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756438 ↗
• MalfunctionMay 24, 2018Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540893 ↗
• MalfunctionAug 9, 2017Break; Break

  ACCORDING TO THE REPORTER, IN THE MIDDLE WAY OF SUTURING, THE THREAD BROKE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.

• Z-2918-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL