VLOC 90 VLOCM0335Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521803343), received between Jul 16, 2022 and Jun 3, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (13 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.

• MalfunctionJun 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE WAS DAMAGED DURING SUTURING. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A THIRD SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133451 ↗
• MalfunctionJun 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE WAS DAMAGED DURING SUTURING. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A THIRD SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133445 ↗
• MalfunctionApr 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A UTERINE SUTURING AFTER A CAESAREAN SECTION, THE SUTURE WAS DAMAGED. IT WAS NOTED THAT FOUR SUTURES WAS USED AND HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774614 ↗
• MalfunctionApr 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A UTERINE SUTURING AFTER A CAESAREAN SECTION, THE SUTURE WAS DAMAGED. IT WAS NOTED THAT FOUR SUTURES WAS USED AND HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774613 ↗
• MalfunctionOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE CAESAREAN SECTION, WHILE ON RESECTION, DURING SUTURING, THE NEEDLE DETACHED FROM THE SUTURE THREAD. A NEW PACKET WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494211 ↗
• MalfunctionApr 24, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROTOMY CESAREAN SECTION, DURING MYOMETRIAL SUTURING USING THE CONTINUOUS SUTURING TECHNIQUE, THE SUTURE BROKE. A NEW DEVICE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175643 ↗
• MalfunctionMar 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY CESAREAN SECTION, DURING THE UTERINE WALL CLOSURE VIA CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE IN THE MIDDLE OF THE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899990 ↗
• MalfunctionJan 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE MYOMETRIAL SUTURING OF A CAESAREAN SECTION, WHEN PERFORMING A CONTINUOUS SUTURING, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602166 ↗
• MalfunctionJul 25, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE, AT THE TIME OF UTERINE SUTURE, THE THREAD SUDDENLY BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391205 ↗
• MalfunctionMay 10, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION VIA LAPAROTOMY, WHILE ON CLOSURE OF THE UTERUS, IT WAS DETERMINED THAT THE BARB WAS NOT EFFECTIVE ENOUGH TO SUTURE THE UTERINE MYOMETRIUM WELL. WHEN COLLECTED AND CHECKED THE ACTUAL PRODUCT, THERE SEEMS TO BE NO PARTICULAR PROBLEM. A NEW MONOFILAMENT SUTURE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902758 ↗
• MalfunctionApr 6, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY CAESAREAN SECTION, DURING CONTINUOUS SUTURE CLOSURE OF THE UTERINE WALL, THE SUTURE BROKE WHEN SUTURING THROUGH THE LOOP. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690103 ↗
• MalfunctionMar 15, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY CESAREAN SECTION, WHEN DIVIDED INTO TWO LAYERS WITH MUSCLE LAYERS, THE TWO SUTURES WERE CUT JUST BY PULLING LIGHTLY DURING THE WOUND/SURGICAL INCISION CLOSURE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545923 ↗
• MalfunctionFeb 8, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PROCEDURE, AT THE TIME OF UTERINE MYOMETRIAL SUTURE VIA CONTINUOUS SUTURES, THE THREAD BROKE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16322415 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHEN THE UTERINE MYOMETRIUM SUTURE WAS COMPLETED, IT WAS FOUND THAT THE UTERINE BALLOON WAS TORN AND RUPTURED, SO THE UTERINE MYOMETRIUM SUTURE THREAD AND THE BALLOON WAS REMOVED. INSTEAD OF REMOVING ALL OF THEM, THE ENDS WERE KEPT SUTURED AS THEY WERE. ONCE AGAIN, A NEW UTERINE BALLOON WAS INSERTED AND A NEW SUTURE WAS USED, AND THE UTERINE MYOMETRIUM SUTURE WERE ADVANCED. ABOUT HALFWAY THROUGH, THE THREAD BROKE. A NEW SUTURE WITH A SINGLE NODE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736380 ↗
• MalfunctionJul 16, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL CAESARIAN SECTION, WHEN THE MYOMETRIUM WAS SUTURED WHILE DOING A CONTINUOUS SUTURE, THE SUTURE GOT BROKEN IN THE MIDDLE OF SUTURING. A NEW SUTURE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15036564 ↗

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