V-Loc 180 VLOCL1413Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521131453), received between Oct 19, 2017 and Apr 3, 2026 — classified as 2 injuries, 20 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN INNER SHUNT/ARTERIOVENOUS FISTULA CREATION, THE NEEDLE AND THREAD DETACHED DURING DERMAL SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773188 ↗
• MalfunctionMar 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DERMAL SUTURE, WHILE PREPARING THE SUTURE AFTER THE PATIENT INCISION, THE NEEDLE WAS DETACHED. ANOTHER NEW SUTURE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618318 ↗
• MalfunctionSep 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, DURING CLOSURE (DERMAL SUTURING), THE LOOP WAS DAMAGED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957163 ↗
• MalfunctionApr 24, 2025Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS NO NEEDLE AT THE TIME THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899086 ↗
• MalfunctionJun 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, AT THE TIME OF SUTURING, THE THREAD BROKE IMMEDIATELY AND COULD NOT BE USED. TO RESOLVE THE ISSUE, ANOTHER DEVICE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464215 ↗
• MalfunctionJan 22, 2024Mechanical Problem; Patient-Device Incompatibility; Mechanical Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER 1.5 MONTHS POSTOPERATIVELY, A DERMAL SUTURE DURING THE WOUND CLOSURE OF THE CAESAREAN SECTION WAS PERFORMED, WHICH WAS USED FOR AN INCISION LAYER OF ABOUT 15CM. A SLIGHT REDNESS AND INFLAMMATION, BUT NO INFECTION WERE OBSERVED ON THE SKIN SURFACE, AND THE THREAD CAME OUT FROM THE BEGINNING PORTION OR EDGE OF THE STITCH. IT WAS NOTED THAT WHEN THE SURGEON USED IT ON THE MYOMETRIUM, IT WAS UNABLE TO SUTURE PROPERLY, AND DIFFERENT SUTURE WAS USED SAFELY. HENCE, A 3 CM THREAD CAME OUT OF THE CENTER AFTER 2 MONTHS OF SURGERY. IT WAS NOTED THAT THE WOUND HAD HEALED WELL, THE THREAD WAS BROKEN, AND TOPICAL ANTIBACTERIAL DRUGS WERE APPLIED. MOREOVER, TWO WEEKS LATER, THE PATIENT RETURNED AS OUTPATIENT. THE DERMAL SUTURE CAME OUT OF THE STOMACH.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18552425 ↗
• InjuryApr 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ABDOMINAL CLOSURE, WHEN SUTURING DERMAL WOUND, AFTER USING 2-3 SUTURES, THE PROXIMAL SITE OF THE NEXT TWO NEEDLES BROKE. THE THREADS WERE NOT PULLED HARD BUT THE THREADS ALSO BROKE. A NEW PACKET WAS TAKEN OUT AND USED TO CONTINUE THE CASE. AN X-RAY WAS PERFORMED TO MAKE SURE ALL PIECES WERE ACCOUNTED FOR. NO COMPONENT FELL INTO THE CAVITY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16731701 ↗
• InjuryMar 20, 2023Break; Product Quality Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem; Break; Product Quality Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING DERMAL SUTURE ON A BREAST REDUCTION PROCEDURE, IT WAS NOTICED THAT THE PROXIMAL SITE OF THE NEEDLE WAS DAMAGED, BUT WAS USED AS IS AND WHEN AFTER PUNCTURING THE FIRST NEEDLE, THE PATIENT'S SKIN (NEAR THE INCISION WOUND) WAS DAMAGED BUT IT WAS SMALLER THAN THE INCISIONAL WOUND. IT WAS ALSO NOTED THAT THE ROOT OF THE NEEDLE CAUGHT DURING INSERTION, CAUSING TISSUE DAMAGE AND UNEXPECTED BLEEDING (TO THE EXTENT THAT IT COULD NOT BE WIPED WITH GAUZE). BECAUSE THE TISSUE DAMAGE WAS SMALL, THE WOUND WAS CLOSED WITH A NEWLY OPENED PACKAGE OF THE SAME LOT TO COMPLETE THE CASE. AN UNANTICIPATED TISSUE LOSS WAS ALSO NOTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16574096 ↗
• MalfunctionJun 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN HOLDING WITH NEEDLE HOLDER, THE NEEDLE CAME OFF BEFORE USE. ANOTHER NEW SUTURE USED WITHOUT ISSUE.

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

  MAUDE report 14749047 ↗
• MalfunctionSep 24, 2021Break; Break

  ACCORDING TO THE REPORTER, AT THE START POINT OF DERMIS SUTURE IN A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN PASSING THROUGH THE END LOOP; THE LOOP BROKE. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526231 ↗
• MalfunctionJan 9, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PRIOR TO USE THE PRODUCT ON PATIENT, THE THREAD BROKE. ANOTHER NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144155 ↗
• MalfunctionJan 6, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INCISION CLOSURE, THE LAST LOOP ON THE DEVICE THREAD WAS FOUND TO BE BROKEN INSIDE THE PACKAGE IMMEDIATELY AFTER OPENING IT, SO THE PRODUCT WAS NOT USED IN PATIENT AND A NEW PACKET WAS OPENED. THE FOLLOWING PACKET WAS CLAIMED TO HAVE BEEN THE NEEDLE IN DETACHED SITUATION AND COULD NOT BE USED. THE SURGEON USED A COMPETITOR'S PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123049 ↗
• MalfunctionJul 19, 2018Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SEWING, THE SUTURE BROKE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703170 ↗
• MalfunctionJun 28, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORACOSCOPIC SURGERY, WHEN THE SURGEON THREADED THROUGH THE LOOP, THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7646112 ↗
• MalfunctionApr 30, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER DURING A WEDGE/SEGMENTAL RESECTION, WHEN A DOCTOR HAD THE NEEDLE GO THROUGH THE LOOP AND PULLED UP THE THREAD, THE LOOP BROKE. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7472746 ↗
• MalfunctionApr 25, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER THE NEEDLE WENT THROUGH THE LOOP, THE THREAD BROKE AT ABOUT 1.5 CM FROM THE LOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7462512 ↗
• MalfunctionMar 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHILE THE SURGEON IS HOLDING THE NEEDLE WITH A FORCEPS AND MADE THE FIRST STITCH PULLING THE THREAD, IT BROKE IMMEDIATELY IN FRONT OF THE LOOP. IT WAS NOTED THAT NO EXCESSIVE FORCE WAS ADDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361992 ↗
• MalfunctionJan 30, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING WEDGE/SEGMENTAL RESECTION, WHEN THE DOCTOR LET THE NEEDLE THROUGH THE LOOP AND TIED IT UP, THE LOOP BROKE. THREE PRODUCTS HAD THE SAME PROBLEM IN A ROW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228826 ↗
• MalfunctionDec 8, 2017Break; Break

  ACCORDING TO THE REPORTER, DEVICE WAS OPENED AND IT WAS NOTICED THAT THE LOOP WAS BROKEN. EVENT OCCURRED DURING SKIN CLOSURE PROCEDURE BUT THE DEVICE WAS NOT USED FOR THE PATIENT INSTEAD THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7101846 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE CAME OFF OF THE THREAD. NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7067646 ↗
• MalfunctionNov 13, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A PROCEDURE. WHILE SUTURING, THE LOOP BROKE WITHOUT ANY ADDED TENSION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7025280 ↗
• MalfunctionOct 19, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LOOP BROKE WHILE SUTURING. NOTHING FELL INTO THE PATIENT CAVITY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6961352 ↗

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