V-Loc 90 VLOCM0124Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 30884521132249), received between Jun 7, 2018 and Nov 10, 2025 — classified as 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY, THE LOOP OF THE SUTURE BROKE PRIOR TO HANDLING AFTER OPENING THE PACKAGE. THE ISSUE WAS RESOLVED BY USING A NEW SUTURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514026 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE AND SNAPPED IN TWO IN THE MIDDLE. FIVE SUTURES WERE USED AND HAD THE SAME ISSUE. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490785 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE AND SNAPPED IN TWO IN THE MIDDLE. FIVE SUTURES WERE USED AND HAD THE SAME ISSUE. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490770 ↗
• MalfunctionNov 6, 2025Break; Break

  PLI- 10, 20, 30, 40, 50 IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE AND SNAPPED IN TWO IN THE MIDDLE. FIVE SUTURES WERE USED AND HAD THE SAME ISSUE. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490767 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE AND SNAPPED IN TWO IN THE MIDDLE. FIVE SUTURES WERE USED AND HAD THE SAME ISSUE. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490759 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE AND SNAPPED IN TWO IN THE MIDDLE. FIVE SUTURES WERE USED AND HAD THE SAME ISSUE. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490704 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, THE DEVICE EXPERIENCED NEEDLE DETACHMENT FROM THE THREAD WHILE SUTURING THE SKIN FOR CLOSURE. THIS ISSUE OCCURRED ON TWO DEVICES. A NEW SUTURE WAS THEN USED 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 23398268 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, THE DEVICE EXPERIENCED NEEDLE DETACHMENT FROM THE THREAD WHILE SUTURING THE SKIN FOR CLOSURE. THIS ISSUE OCCURRED ON TWO DEVICES. A NEW SUTURE WAS THEN USED 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 23398176 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, PREOPERATIVELY, THE TWO STRANDS OF THE DEVICE WERE TAKEN FROM THE PACKAGE, WHILE PUTTING THE DEVICES ONTO THE INSTRUMENT, THE NEEDLE DETACHED FROM THE SUTURE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282698 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, PREOPERATIVELY, THE TWO STRANDS OF THE DEVICE WERE TAKEN FROM THE PACKAGE, WHILE PUTTING THE DEVICES ONTO THE INSTRUMENT, THE NEEDLE DETACHED FROM THE SUTURE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22241994 ↗
• MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN IT WAS OPENED, IT WAS FOUND OUT THAT THE NEEDLE AND THREAD SEPARATED OUTSIDE THE RETAINER/HOLDER. IT WAS NOTED IT WAS NOT USED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238370 ↗
• MalfunctionAug 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A KNEE REPLACEMENT PROCEDURE, AFTER OPENING THE PACKAGE IT WAS FOUND THAT THE NEEDLE DETACHED FROM THE THREAD. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920248 ↗
• MalfunctionJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN RADICAL MASTECTOMY, WHILE SUTURING THE BREAST TISSUE USING CONTINUOUS SUTURING TECHNIQUE, AFTER 3-5 STITCHES, THE NEEDLE AND THREAD BROKE FOR THE FOUR SUTURE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043587 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UTERINE MYOMECTOMY PROCEDURE, WHEN SEWING THE SKIN, THE NEEDLE WAS SEPARATED FROM THE THREAD WHEN OPENING THE PACKAGE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612618 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, WHILE SUTURING FOR CLOSING USING THE RUNNING STITCH TECHNIQUE, THE THREAD BROKE. WITH ANOTHER SUTURE, THE NEEDLE POPPED-OFF. THE SAME ISSUES OCCURRED WITH SUTURES FROM ANOTHER LOT. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16103356 ↗
• MalfunctionJan 5, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, WHILE SUTURING FOR CLOSING USING THE RUNNING STITCH TECHNIQUE, THE THREAD BROKE. WITH ANOTHER SUTURE, THE NEEDLE POPPED-OFF. THE SAME ISSUES OCCURRED WITH SUTURES FROM ANOTHER LOT. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16103288 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, WHILE SUTURING FOR CLOSING USING THE RUNNING STITCH TECHNIQUE, THE NEEDLE POPPED-OFF. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103163 ↗
• MalfunctionJan 5, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, WHILE SUTURING FOR CLOSING USING THE RUNNING STITCH TECHNIQUE, THE THREAD BROKE. WITH ANOTHER SUTURE, THE NEEDLE POPPED-OFF. THE SAME ISSUES OCCURRED WITH SUTURES FROM ANOTHER LOT. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16103075 ↗
• MalfunctionJan 5, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE OF THE SKIN, WHILE SUTURING VIA A RUNNING TECHNIQUE, THE SUTURE BROKE. THE SURGEON OPENED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102754 ↗
• MalfunctionAug 10, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN MAMMARY GLAND SURGERY, WITH A CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE AFTER SIX STITCHES WERE SUTURED ONE MINUTES AFTER THE DEVICE WAS REMOVED FROM THE PACKAGING. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT INJURY. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201857 ↗
• MalfunctionAug 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SUTURING THE BREAST IN AN OPEN BREAST SURGERY, AFTER 4-6 STITCHES DURING CONTINUOUS SUTURING THE NEEDLE AND THREAD BROKE. SURGEON OPENED ANOTHER SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178220 ↗
• MalfunctionMay 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MAMMARY CANCER RADICAL CURE PROCEDURE, WHILE SUTURING THE BREAST, BOTH NEEDLE AND THREAD BROKE. THE SURGEON TOOK ANOTHER PACK OF SUTURE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14367239 ↗
• InjuryJan 14, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN BREAST SEGMENT PROCEDURE, WHILE SUTURING THE GLAND, THE TIP OF THE NEEDLE BROKE AND FELL OFF. X-RAY WAS DONE AND WAS SHOWING A 0.7MM NEEDLE. THE SURROUNDING TISSUES WERE REMOVED, AND ANOTHER X-RAY WAS DONE SHOWING A NORMAL RESULT. THE SURGERY WAS PROLONGED FOR 30 MINUTES AND THE INCISION WAS EXTENDED, BUT NOT MORE THAN 1 INCH.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 13261113 ↗
• MalfunctionDec 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY BYPASS, THE NEEDLE DETACHED FROM THE THREAD WHILE SUTURING THE STAPLE LINE OF THE STOMACH. THE SURGEON USED A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13108484 ↗
• MalfunctionAug 6, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTRIC SLEEVE PROCEDURE, WHILE USING THE DEVICE ON THE STOMACH, THE SUTURE THREAD 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 12288373 ↗

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