V-Loc 90 VLOCM0336Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521132504), received between Jun 27, 2022 and Jul 31, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jun 24, 2026Open, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2918-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC MYOMECTOMY WHILE USING THE FIRST SUTURE, THE THREAD DETACHED FROM THE NEEDLE. A SECOND SUTURE WAS USED, BUT THE MATERIAL OF THE SUTURE STARTED TO TEAR. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674596 ↗
• MalfunctionJul 31, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC MYOMECTOMY WHILE USING THE FIRST SUTURE, THE THREAD DETACHED FROM THE NEEDLE. A SECOND SUTURE WAS USED, BUT THE MATERIAL OF THE SUTURE STARTED TO TEAR. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674565 ↗
• MalfunctionApr 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CESARIAN SECTION, THE FIRST SUTURE BROKE IN THE MIDDLE WHILE SUTURING. TO RESOLVE THE ISSUE, A NEW PACKET WAS OPENED, AND AFTER SECURING THE SUTURE, THE NEEDLE DETACHED. A NEEDLE WITH AN EYE WAS THEN FETCHED TO THREAD THE SUTURE SO THE STRAND COULD STILL BE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922354 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A CESARIAN SECTION, THE FIRST SUTURE BROKE IN THE MIDDLE WHILE SUTURING. TO RESOLVE THE ISSUE, A NEW PACKET WAS OPENED, AND AFTER SECURING THE SUTURE, THE NEEDLE DETACHED. A NEEDLE WITH AN EYE WAS THEN FETCHED TO THREAD THE SUTURE SO THE STRAND COULD STILL BE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922337 ↗
• MalfunctionFeb 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION, THE NEEDLE WAS DETACHED. TO RESOLVE THE ISSUE, THE SUTURE THAT GOT DETACHED FROM THE NEEDLE WAS CUT AND FLUSH WITH THE TISSUE, AND TO COMPLETE THE CASE ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333656 ↗
• MalfunctionNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION, THE NEEDLE WAS DETACHED. TO RESOLVE THE ISSUE, THE SUTURE THAT GOT DETACHED FROM THE NEEDLE WAS CUT AND FLUSH WITH THE TISSUE, AND TO COMPLETE THE CASE ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705690 ↗
• MalfunctionMay 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, ON A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE. A SECOND SUTURE FROM THE SAME LOT AND BATCH NUMBER HAD TO OPEN BUT ALSO HAD THE SAME ISSUE. ANOTHER BOX WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236194 ↗
• MalfunctionApr 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CAESARIAN SECTION, WHEN CLOSING THE UTERUS VIA CONTINUOUS SUTURING TECHNIQUE, BEFORE USING IT, THE ABSORBABLE SUTURE BROKE. HENCE, WHEN ALSO CLOSING THE SKIN VIA THE CONTINUOUS SUTURING TECHNIQUE, AFTER THE FIRST THROW, THE 3-0 ABSORBABLE SUTURE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031895 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 18871338 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 18871321 ↗
• MalfunctionFeb 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, ON A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER BOX WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740743 ↗
• MalfunctionDec 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406779 ↗
• MalfunctionNov 30, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, ON THE CLOSURE OF THE UTERUS, THE TWO SUTURES SNAPPED WHILE PULLING IT THROUGH THE TISSUE. THE SURGEON THEN REQUESTED ANOTHER ABSORBABLE SUTURE TO CONTINUE CLOSING OFF THE UTERUS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242356 ↗
• MalfunctionNov 30, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, ON THE CLOSURE OF THE UTERUS, THE TWO SUTURES SNAPPED WHILE PULLING IT THROUGH THE TISSUE. THE SURGEON THEN REQUESTED ANOTHER ABSORBABLE SUTURE TO CONTINUE CLOSING OFF THE UTERUS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242318 ↗
• MalfunctionJan 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CESAREAN SECTION, FORTY MINUTES INTO THE PROCEDURE, AT UTERINE CLOSURE, THE THREAD BROKE. ANOTHER SUTURE FROM THE SAME LOT WAS OPENED BUT THE SAME THING OCCURRED. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270707 ↗
• MalfunctionDec 20, 2022Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN CAESARIAN SECTION, DURING CLOSING USING THE UNINTERRUPTED SUTURE TECHNIQUE, THE THREAD BROKE. TOO MUCH TENSION WAS PUT ONTO THE DEVICE DUE TO THE PROCEDURE. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THE SURGEON COMPLETED ANOTHER LAYER TO MAKE SURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019408 ↗
• MalfunctionSep 9, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON AN OPEN C-SECTION, IN THE MIDDLE OF CLOSING UTERUS FOR THE UTERINE REPAIR USING THE LOCKING STITCH TEC HNIQUE, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394725 ↗
• MalfunctionSep 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGERY, WHEN IN THE MIDDLE OF CLOSING THE FASCIA, THE THREAD BROKE WHILE THE SURGEON WAS DOING THE LOCKING SUTURING TECHNIQUE. A NEW SUTURE WAS USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380163 ↗
• MalfunctionJun 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SPINAL DEFORMITY CORRECTION, AT THE TIME OF SKIN CLOSURE, THE SUTURE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 14834248 ↗