V-Loc 90 VLOCM1413Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521132788), received between Jul 25, 2017 and Dec 29, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE AND SUTURE CAME OFF EASILY. THERE WAS NO LOOP AT THE END. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075038 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THYROID TUMORECTOMY PROCEDURE, IN WOUND CLOSURE, THE NURSE OPENED THE PACKET AND CLAMPED THE NEEDLE WITH FORCEPS, THEN THE THREAD CAME OFF, THE NEEDLE SEPARATED AS A WHOLE. TO RESOLVE THE ISSUE, A NEW SUTURE WITH THE SAME LOT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375165 ↗
• MalfunctionMar 25, 2021Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING SURGICAL INCISION CLOSURE FOR THYROID CANCER, THE THREAD WAS PULLED OUT WHEN THE NEEDLE WAS PUT THROUGH THE LOOP AT THE END OF THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568325 ↗
• MalfunctionNov 6, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE BROKE BUT DID NOT FELL INTO THE PATIENT'S CAVITY. ANOTHER SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10799783 ↗
• MalfunctionSep 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY, THE THREAD BROKE WHILE STITCHING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10597010 ↗
• MalfunctionSep 4, 2020Break; Break

  ACCORDING TO THE REPORTER, AT THE FIRST STITCH DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE ATTEMPTING TO CLOSE THE SURGICAL INCISION, THE PRODUCT WAS NOT USED IN PATIENT, THE NEEDLE BROKE WHEN HELD WITH A NEEDLE HOLDER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10492985 ↗
• MalfunctionOct 15, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE FIRST SUTURE BROKE, WHILE THE LOOP OF THE SECOND SUTURE WAS BROKEN. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7964788 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A THYROIDECTOMY. THE LOOP BROKE. TO COMPLETE THE PROCEDURE, ANOTHER SUTURE WAS OPENED BUT THAT LOOP WAS BROKEN DISCOVERED TO BE BROKEN IN THE PACKAGE. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316641 ↗
• MalfunctionJan 5, 2018Break; Break

  ACCORDING TO THE REPORTER, THE LOOP OF THE DEVICE WAS BROKEN PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7168773 ↗
• MalfunctionNov 21, 2017Break; Break

  ACCORDING TO THE REPORTER, THERE WAS NO LOOP IN THE DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7050241 ↗
• MalfunctionOct 5, 2017Break; Break

  ACCORDING TO THE REPORTER, OCCURRED DURING A THYROIDECTOMY PROCEDURE. WHEN THE SURGEON HAD THE NEEDLE THROUGH THE LOOP AND TIGHTENED, THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915039 ↗
• MalfunctionJul 25, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OTOLARYNGOLOGY SURGERY. THE LOOP BROKE. THE USER TRIED TO USE THE THREAD AS IT WAS, BUT THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. PATIENT STATUS IS WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6740761 ↗

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