V-Loc 180 VLOCL0803Recalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10884521131279), received between Apr 27, 2017 and Aug 27, 2026 — classified as 11 injuries, 146 malfunctions.

The most frequently reported specific device problem is “Break” (89 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 157 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  According to the reporter, during a laparoscopic radical thyroidectomy for thyroid cancer, the needle broke, making it unusable and affecting surgical efficiency, which could have delayed the patient¿s treatment. The physician immediately replaced the product to resolve the issue. There was no patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50480364 ↗
• MalfunctionAug 27, 2026Break; Detachment of Device or Device Component

  It was reported that during an open removal of left femoral plate internal fixation procedure, the suture thread broke during skin s uturing and the needle detached. The broken suture was partially explanted and replaced with another suture 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 50470400 ↗
• MalfunctionAug 21, 2026Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372793 ↗
• MalfunctionJun 15, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A PEDIATRIC VENTRICULAR SEPTAL DEFECT REPAIR UNDER GENERAL ANESTHESIA, DURING SUBCUTANEOUS MUSCLE LAYER SUTURING, THE BARBED SUTURE BROKE VERY EASILY SO IT COULD NOT BE USED FOR SMOOTH SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS DELAYED FOR ABOUT 10 MINUTES DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498265 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE DOCTOR WAS SUTURING TISSUE, THE SUTURE USED EXPERIENCED NEEDLE¿SUTURE SEPARATION AND COULD NOT CONTINUE TO BE USED. THE SUTURE WAS IMMEDIATELY REPLACED. THE SUTURING TIME WAS PROLONGED.

  Patient problems: Insufficient Information

  MAUDE report 25490641 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC ALVEOLI RESECTION, WHEN THE SCRUB NURSE OPENED THE PACKAGE AND CLAMPED THE NEEDLE, IT WAS FOUND THAT THE NEEDLE HAD DETACHED FROM THE SUTURE. THE CIRCULATING NURSE WAS IMMEDIATELY INFORMED, AND THE SUTURE WAS REPLACED TO CONTINUE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480031 ↗
• MalfunctionApr 20, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC EXPLORATION, CHOLECYSTECTOMY, COMMON BILE DUCT STONE REMOVAL, AND PRIMARY CLOSURE OF THE COMMON BILE DUCT, DURING SUTURING, THE SUTURE BROKE WHEN IT WAS CLAMPED TOO TIGHT WITH THE NEEDLE HOLDER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926288 ↗
• MalfunctionApr 14, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE THREAD DETACHED. AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876042 ↗
• MalfunctionApr 4, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WAS SUTURING THE TISSUE AFTER PROPER ALIGNMENT, THE SUTURE BROKE. THE SUTURE WAS REPLACED AND RE-SUTURING WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24784486 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN SCAR REMOVAL, AT THE TIME OF SKIN SUTURING, TEN MINUTES INTO THE PROCEDURE, TWO SUTURE THREADS BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619377 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN SCAR REMOVAL, AT THE TIME OF SKIN SUTURING, TEN MINUTES INTO THE PROCEDURE, TWO SUTURE THREADS BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619255 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE SUTURE BROKE WHILE CLOSING THE HERNIA RING DURING SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089488 ↗
• InjuryDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNILATERAL INGUINAL HERNIA, THE SUTURE BROKE AWAY FROM THE NEEDLE, RESULTING IN THE NEEDLE FALLING INTO THE ABDOMINAL CAVITY. THE NEEDLE WAS LATER LOCATED USING A C-ARM X-RAY MACHINE. THIS INCIDENT PROLONGED THE SURGERY AND AFFECTED THE PATIENT'S RECOVERY. THERE WERE CONCOMITANT INSTRUMENTS INVOLVED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23830794 ↗
• MalfunctionDec 17, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON FOUND IT DIFFICULT TO TIGHTEN THE SUTURE WHEN TYING KNOTS, AND THE SUTURE EXHIBITED POOR COMPLIANCE. A NEW SUTURE WAS IMMEDIATELY USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825064 ↗
• MalfunctionDec 9, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED RIGHT LOWER LOBE RESECTION, THE FIRST TWO STITCHES OF THE DERMAL SUTURE WAS APPLIED TO THE TISSUE, AND WHEN THE NEEDLE WAS PASSED THROUGH THE LOOP AND PULLED WITH AN APPROPRIATE FORCE, THE LOOP BROKE. WHEN IT WAS REPLACED WITH THE SAME NEW PRODUCT, THE LOOP DID NOT BREAK EVEN THOUGH WE PULLED IT WITH THE SAME FORCE AS LAST TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759820 ↗
• MalfunctionOct 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE FIRST KNOT WAS SECURED WITHOUT APPLYING EXCESSIVE TENSION, BUT THE REAR LOOP BROKE AFTERWARDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307766 ↗
• MalfunctionOct 15, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A COMMON BILE DUCT EXPLORATION AND STONE REMOVAL SURGERY, AFTER OPENING THE BARBED SUTURE, THE SUTURE BROKE AT THE SUTURE SITE. ANOTHER SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293183 ↗
• MalfunctionSep 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE PULLING THE THREAD ON THE FIRST STITCH, THE THREAD BROKE IN THE MIDDLE. AS SUTURING CONTINUED, THE NEEDLE SEPARATED FROM THE SUTURE AS A WHOLE AND THEN BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001935 ↗
• MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE AND THREAD WERE DISCONNECTED.

  Patient problems: Insufficient Information

  MAUDE report 22960755 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT A LAPAROSCOPIC HEPATOBILIARY SURGERY, THE SUTURE THREAD BROKE BEFORE ENTERING THE BODY, SPECIFICALLY WHEN BEING PREPARED FOR PLACEMENT INTO THE SHEATH PORT. THE ISSUE WAS RESOLVED BY REPLACING THE BROKEN SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914142 ↗
• MalfunctionAug 7, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DUPLICATE OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737370 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN THYROID SURGERY, THE SUTURE THREAD BROKE UPON OPENING THE PACKAGE, PRIOR TO USE AND BEFORE ANY CONTACT WITH TISSUE. THIS REQUIRED OPENING A NEW PACKAGE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722713 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SUTURING, THE NEEDLE DETACHED FROM THE THREAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632576 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE SHAFT AND SUTURE BROKE DURING SKIN PUNCTURE, MAKING IT IMPOSSIBLE TO COMPLETE THE SUTURING PROCESS AND CAUSED DAMAGE TO THE PUNCTURE SITE. THE BROKEN SUTURE WAS IMMEDIATELY REMOVED, AND A NEW ONE WAS USED TO CONTINUE THE SUTURING PROCESS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22628487 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY, SPECIFICALLY AT THE VESICOURETHRAL ANASTOMOSIS STEP, THE SUTURE EXPERIENCED THREAD BREAKAGE WITHIN A FEW MINUTES OF USE. THERE WERE FOUR CONSECUTIVE OCCURRENCES OF SUTURE BREAKAGE INVOLVING DEVICES FROM THE SAME PRODUCT AND LOT DURING THE SAME CASE. THIS RESULTED IN TISSUE DAMAGE THAT REQUIRED MULTIPLE RE-SUTURING. THE ISSUE WAS RESOLVED BY REOPENING A NEW SUTURE TO COMPLETE THE PROCEDURE.

  Patient problems: Tissue Breakdown

  MAUDE report 22583122 ↗

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