V-Loc 180 VLOCL0325Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521130999), received between Jan 31, 2018 and Sep 28, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50917252 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  According to the reporter, during a right thoracoscopic lobectomy, at the end of the operation, when the physician used the suture to close the incision, the needle separated from the suture, and it could not be used. Another suture was replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482673 ↗
• MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC TRAUMA SURGERY, DURING SOFT TISSUE SUTURING, FIVE MINUTES LATER, THE THREAD DETACHED FROM THE NEEDLE. A NEW SUTURE FROM ANOTHER BRAND WAS USED TO RESUTURE THE TISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476255 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTRACRANIAL HEMATOMA EVACUATION (OPEN PROCEDURE), WHILE SUTURING THE GALEA APONEUROTICA. THE FIRST SUTURE THREAD BROKE AFTER THREE STITCHES, AND AFTER SWITCHING TO A NEW SUTURE, THE SECOND THREAD BROKE AFTER TWO STITCHES. BOTH INCIDENTS OCCURRED WITHIN FIVE MINUTES OF THE PROCEDURE, USING A CONTINUOUS SUTURE TECHNIQUE. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, SUTURES FROM ANOTHER MANUFACTURER WERE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095569 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTRACRANIAL HEMATOMA EVACUATION (OPEN PROCEDURE), WHILE SUTURING THE GALEA APONEUROTICA. THE FIRST SUTURE THREAD BROKE AFTER THREE STITCHES, AND AFTER SWITCHING TO A NEW SUTURE, THE SECOND THREAD BROKE AFTER TWO STITCHES. BOTH INCIDENTS OCCURRED WITHIN FIVE MINUTES OF THE PROCEDURE, USING A CONTINUOUS SUTURE TECHNIQUE. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, SUTURES FROM ANOTHER MANUFACTURER WERE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095509 ↗
• MalfunctionJul 16, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHEN SEWING THE FIRST STITCH, THE THREAD BROKE.

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

  MAUDE report 22517350 ↗
• MalfunctionJul 15, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHEN SEWING THE FIRST STITCH, THE THREAD BROKE. THE SECOND SUTURE HAD THE SAME ISSUE.

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

  MAUDE report 22508881 ↗
• MalfunctionJul 15, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHEN SEWING THE FIRST STITCH, THE THREAD BROKE. THE SECOND SUTURE HAD THE SAME ISSUE.

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

  MAUDE report 22508703 ↗
• InjuryJul 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY. THE ABSORBABLE SUTURE WAS USED DURING THE OPERATION. THE DOCTOR FOUND THAT THE INCISION RUPTURED AND EXUDATED DURING THE ROUNDS. AFTER THE EMERGENCY OPERATION, IT WAS FOUND THAT THE BARBED THREAD WAS BROKEN AFTER THE REMOVAL. IT WAS RE-SUTURED AND RECOVERED WELL AFTER THE OPERATION.

  Patient problems: Purulent Discharge; Rupture

  MAUDE report 22392986 ↗
• MalfunctionJun 27, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, THE THREAD BROKE NEXT TO THE LOOP OF THE DEVICE. A NEW SUTURE WAS USED, BUT THE SUTURE LINE DID NOT HOLD. 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 22351757 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, THE THREAD BROKE NEXT TO THE LOOP OF THE DEVICE. A NEW SUTURE WAS USED, BUT THE SUTURE LINE DID NOT HOLD. 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 22351752 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, THE THREAD BROKE NEXT TO THE LOOP OF THE DEVICE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350574 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, THE THREAD BROKE NEXT TO THE LOOP OF THE DEVICE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350436 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, THE THREAD BROKE NEXT TO THE LOOP OF THE DEVICE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350337 ↗
• MalfunctionJun 27, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, THE THREAD BROKE NEXT TO THE LOOP OF THE DEVICE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22350284 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER AND PREPARING THE SUTURE PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298544 ↗
• MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE PACKAGE WAS OPENED, THE CONNECTION BETWEEN NEEDLE AND THREAD BROKE WHEN THERE WAS NO PULLING DURING ONE STITCH. IT COULD NOT BE USED NORMALLY, AND REPLACED IT WITH A NEW NEEDLE AND THREAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735295 ↗
• MalfunctionJan 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY WHEN THE PACKAGE WAS OPENED IT WAS FOUND THAT THE NEEDLE WAS DETACHED FROM THE SUTURE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179445 ↗
• MalfunctionNov 25, 2024Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHEN THE SUTURE WAS ABOUT TO BE USED, THE NURSE OPENED THE SUTURE AND FOUND THAT THE NEEDLE AND THREAD WERE BROKEN. THE SUTURE COULD NOT BE USED. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771243 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD AND SUTURE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032116 ↗
• MalfunctionJun 30, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE BROKE. CHANGED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238179 ↗
• MalfunctionJun 30, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE OF TWELVE SUTURES BROKE. THE USER CHANGED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237629 ↗
• MalfunctionMar 3, 2023Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PATIENT UNDERWENT LAPAROSCOPIC SUBTOTAL HYSTERECTOMY FOR UTERINE FIBROIDS, THE WOUND WAS SUTURED AT THE END OF THE SURGERY, THE ABSORBABLE SUTURE WAS BROKEN SUDDENLY DUE TO EXCESSIVE FORCE AND CAUSED A SLIGHT STRAIN ON THE WOUND. THE USER IMMEDIATELY REPLACED WITH NEW ABSORBABLE SUTURE TO COMPLETE THE SUTURE, AND THE SURGERY WAS OVER. THERE WAS NO PATIENT INJURY.

  Patient problems: Localized Skin Lesion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478834 ↗
• MalfunctionJan 20, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT, WHILE CLOSING, THE THREAD BROKE. ANOTHER PRODUCT WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216625 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THE SUTURE WERE DETACHED, HENCE THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072992 ↗

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