V-Loc 90 VLOCM0844Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521139596), received between Sep 18, 2018 and Mar 10, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE INVOLVING THE DEVICE, THE SUTURE BROKE WHILE IN USE. A SECOND SUTURE WAS USED FROM THE SAME PACK ALSO SNAPPED DURING THE SAME EVENT WITH THE SAME PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561688 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE INVOLVING THE DEVICE, THE SUTURE BROKE WHILE IN USE. A SECOND SUTURE WAS USED FROM THE SAME PACK ALSO SNAPPED DURING THE SAME EVENT WITH THE SAME PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561681 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568791 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568331 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE LIGATURE WIRE BROKE AND LOOSENED SEVERAL TIMES. THE THREAD CAME OFF THE NEEDLE WITHOUT BEING POWERED ON. THE ISSUE OCCURRED ON THREE (3) SUTURES FROM THE SAME BATCH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE ISSUE CAUSED LOSS OF TIME.

  Patient problems: Insufficient Information

  MAUDE report 16815399 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE LIGATURE WIRE BROKE AND LOOSENED SEVERAL TIMES. THE THREAD CAME OFF THE NEEDLE WITHOUT BEING POWERED ON. THE ISSUE OCCURRED ON THREE (3) SUTURES FROM THE SAME BATCH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE ISSUE CAUSED LOSS OF TIME.

  Patient problems: Insufficient Information

  MAUDE report 16815358 ↗
• MalfunctionMar 24, 2023Break; Device Slipped; Detachment of Device or Device Component; Break; Device Slipped; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE LIGATURE WIRE BROKE AND LOOSENED SEVERAL TIMES. THE THREAD CAME OFF THE NEEDLE WITHOUT BEING POWERED ON. THE ISSUE OCCURRED ON THREE (3) SUTURES FROM THE SAME BATCH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE ISSUE CAUSED LOSS OF TIME.

  Patient problems: Insufficient Information

  MAUDE report 16612580 ↗
• MalfunctionNov 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA OPERATION, THE THREAD FROM THE THREE SUTURES CAME OFF THE NEEDLE WITHOUT TENSION, NO STITCHED WERE MADE. THERE WAS LOSS OF TIME DUE TO THE MALFUNCTION. A NEW SUTURE FROM DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845918 ↗
• MalfunctionJul 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF THE DEVICE BROKE. THE DEVICE WAS NOT USED ON THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15132224 ↗
• MalfunctionJul 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LEFT INGUINAL HERNIA REPAIR WITH MESH PROCEDURE, THE THREAD OF THE DEVICE BROKE. A SECOND DEVICE WAS OPENED, AND THE SURGEON MADE FEW STITCHES AND THE DEVICE BROKE AGAIN. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104086 ↗
• MalfunctionSep 18, 2018Break; Break

  ACCORDING TO THE REPORTER, TWO AND HALF HOUR INTO A ROBOTIC LAPAROSCOPIC GASTRIC BYPASS PROCEDURE AND THEY WERE HALF WAY THROUGH USING THE SUTURE IN THE JEJUNUM OF THE PATIENT WHEN THE THREAD OF THE SUTURE BROKE. THEY NOTED THAT THE SUTURING TECHNIQUE THEY WERE USING WAS RUNNING STITCH. THEY TIED THE THREAD AND THEY CONTINUED TO USE THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886028 ↗

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