V-Loc 90 VLOCM1744Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10884521132900), received between Sep 28, 2017 and Jul 8, 2026 — classified as 2 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Break” (62 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 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE BEING USED TO CLOSE THE PATIENT¿S WOUND, THE MIDDLE PORTION OF THE SUTURE BROKE. AFTER THE ISSUE WAS DISCOVERED, THE SUTURE WAS IMMEDIATELY REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750025 ↗
• MalfunctionJun 19, 2026Break

  ACCORDING TO THE REPORTER, DURING A DA VINCI PROSTATECTOMY, WHILE SUTURING, THE THREAD BROKE IN TWO PLACES WITHOUT ANY EXTRAORDINARY FORCE BEING APPLIED.

  Patient problems: Insufficient Information

  MAUDE report 25556884 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE SUTURE BROKE IN THE MIDDLE WHILE THE PHYSICIAN WAS PULLING THE THREAD. THIS CAUSED BLEEDING AND PROLONGED THE OPERATION TIME. ANOTHER SUTURE WAS IMMEDIATELY USED INSTEAD AND THE SUTURING WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25513891 ↗
• MalfunctionMay 27, 2026Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE SUTURING THE SOFT TISSUE. THE TAIL END OF THE BARBED SUTURE BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296719 ↗
• InjuryApr 29, 2026Break

  IT WAS REPORTED THAT INTRAOPERATIVELY, DURING INTRODUCTION OF THE SUTURE THREAD INTO THE TROCAR, THE NEEDLE BROKE AND REMAINED INSIDE THE BODY CAVITY. IT WAS REPORTED THAT EXTRACTION OF THE RETAINED NEEDLE FRAGMENT WAS REQUIRED AND THAT X-RAYS WERE PERFORMED ON THE SAME DAY OF THE EVENT. THE NEEDLE FRAGMENT WAS RETRIEVED BY USING A GRASPER. IT WAS NOTED THAT THE PATIENT IS ALIVE AND WELL.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 25030183 ↗
• MalfunctionMar 31, 2026Break

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE PROCEDURE, AN ABSORBABLE SURGICAL BARBED SUTURE WAS FOUND TO HAVE A DAMAGED LOOP AT THE END OF THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741692 ↗
• MalfunctionFeb 18, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY REQUIRING TISSUE CLOSURE, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385051 ↗
• MalfunctionFeb 12, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY FOR PROSTATE CANCER, AFTER THE SURGEON CLAMPED THE SUTURE NEEDLE WITH A NEEDLE HOLDER, THE SUTURE BROKE WHEN THE THREAD WAS PULLED BY HAND, WHICH PROLONGED THE PROCEDURE BY APPROXIMATELY FIVE MINUTES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328912 ↗
• MalfunctionFeb 5, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. TO RESOLVE THE ISSUE, THE PRODUCT WAS REPLACED AND IMMEDIATELY TAKEN OUT OF USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272300 ↗
• MalfunctionJan 3, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY FOR PROSTATE CANCER, SPECIFICALLY AT THE BLADDER-URETHRAL ANASTOMOSIS STEP, THE TWO BARBED SUTURE THREADS BROKE. THE BREAKAGE OCCURRED INSTANTLY DURING CONTINUOUS SUTURING. THE SUTURE WAS REPLACED TO COMPLETE THE PROCEDURE, AND 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 23952904 ↗
• MalfunctionJan 3, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY FOR PROSTATE CANCER, SPECIFICALLY AT THE BLADDER-URETHRAL ANASTOMOSIS STEP, THE TWO BARBED SUTURE THREADS BROKE. THE BREAKAGE OCCURRED INSTANTLY DURING CONTINUOUS SUTURING. THE SUTURE WAS REPLACED TO COMPLETE THE PROCEDURE, AND 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 23952902 ↗
• MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC RADICAL PROSTATECTOMY FOR PROSTATE CANCER, AT THE INITIATION OF SUTURING, THE SUTURE EXPERIENCED NEEDLE DETACHMENT. THE DEVICE WAS USED IMMEDIATELY AFTER BEING UNPACKED, AND A CONTINUOUS SUTURING TECHNIQUE WAS EMPLOYED. THE ISSUE WAS RESOLVED BY REPLACING THE PRODUCT WITH A NEW SUTURE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915215 ↗
• MalfunctionDec 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY FOR PROSTATE CANCER, THE SUTURE THREAD BROKE WHILE TISSUE SUTURING WAS BEING PERFORMED. AS A RESULT OF THE EVENT, THE SURGERY TIME WAS PROLONGED BY MORE THAN 30 MINUTES. THE ISSUE WAS RESOLVED BY REPLACING THE BROKEN THREAD WITH A NEW SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892363 ↗
• MalfunctionDec 17, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL PROSTATECTOMY , THE ABSORBABLE SUTURE WAS USED FOR CONTINUOUS TISSUE SUTURING. THE SUTURE BROKE DURING THE PROCESS, MAKING IT IMPOSSIBLE TO CONTINUE SUTURING. ANOTHER NEW SUTURE WAS IMMEDIATELY USED INSTEAD. THE WAITING PERIOD PROLONGED THE SURGERY FOR MORE THAN 30 MINUTES AND POSED A POTENTIAL RISK OF BLEEDING.

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

  MAUDE report 23835008 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE PACKAGE OF THE SUTURE WAS OPENED, THERE WAS NO LOOP AT THE END OF THE SUTURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891668 ↗
• MalfunctionAug 1, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC JOINT REPLACEMENT, WHEN SUTURING THE WOUND, THE SUTURE BROKE. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687015 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, THREE SUTURES BROKE IN SUCCESSION. THE FIRST SUTURE BROKE NEAR THE END OF ITS USE AFTER BEING HELD AND MANIPULATED BY LARGE NEEDLE DRIVERS. THE SECOND SUTURE BROKE ALMOST INSTANTLY AFTER BEING HELD BY THE NEEDLE DRIVERS. THE THIRD SUTURE BROKE IN A SIMILAR MANNER TO THE FIRST, AFTER APPROXIMATELY FIVE MINUTES OF USE. ALL THREE SUTURES BROKE ABOUT ONE-THIRD OF THE WAY DOWN THE SUTURE, NOT AT THE END NEAR THE NEEDLE. IT WAS REPLACED WITH A WORKING SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644128 ↗
• MalfunctionJul 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO PIECES OF THE ABSORBABLE WOUND SUTURES WERE BROKEN WHEN KNOTTED WITHOUT FORCE USE. TO RESOLVE THE ISSUE, TWO NEW SUTURES WERE USED.

  Patient problems: Insufficient Information

  MAUDE report 22520806 ↗
• MalfunctionJul 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO PIECES OF THE ABSORBABLE WOUND SUTURES WERE BROKEN WHEN KNOTTED WITHOUT FORCE USE. TO RESOLVE THE ISSUE, TWO NEW SUTURES WERE USED.

  Patient problems: Insufficient Information

  MAUDE report 22520712 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROSTATE SURGERY, AFTER THE FIRST STITCH, THE NEEDLE AND THREAD DETACHED. THE NEEDLE WAS REMOVED AND REPLACED WITH A NEW SUTURE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487745 ↗
• MalfunctionJul 11, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE DOCTOR WAS SUTURING THE PATIENT'S WOUND, THE SUTURE BROKE. AFTER DISCOVERING THIS, THE SUTURE WAS IMMEDIATELY REPLACED WITH ANOTHER ONE FOR SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479694 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, THE ABSORBABLE WOUND SUTURE WAS USED BUT THE THREAD AND NEEDLE WERE DETACHED AND COULD NOT BE USED ANY FURTHER. TO RESOLVE THE ISSUE, THE PATIENT WAS THEN GIVEN THE NEW CONSUMABLE FOR SUTURING.

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

  MAUDE report 22175575 ↗
• MalfunctionMay 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROSTATE CANCER REMOVAL SURGERY, THE SUTURE WAS BROKEN. A NEW SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102123 ↗
• MalfunctionMar 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, AFTER OPENING THE PACKAGE, THE DEVICE WAS PULLED OUT BUT THE THREAD 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 21725173 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY WHEN SUTURING PROCEDURE INVOLVING THE DEVICE, THE SUTURE BROKE WHILE SUTURING. A TOTAL OF 11 DEFECTIVE SUTURES WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT, AND THE OTHER DEFECTIVE DEVICES WERE FROM THE SAME PRODUCT ID AND LOT NUMBER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721368 ↗

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