V-Loc 90 VLOCM1204Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521132764), received between Dec 15, 2017 and Jun 7, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DETACHED WHEN WITHDRAWING FROM THE RETAINER PRIOR TO PATIENT USE. ADDITIONALLY, IT WAS NOTED THAT THE LOOP WAS DAMAGED AFTER OPENING.

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

  MAUDE report 22163922 ↗
• MalfunctionJun 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DETACHED WHEN WITHDRAWING FROM THE RETAINER PRIOR TO PATIENT USE. ADDITIONALLY, IT WAS NOTED THAT THE LOOP WAS DAMAGED AFTER OPENING.

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

  MAUDE report 22163252 ↗
• MalfunctionNov 18, 2024Break; Break

  ACCORDING TO THE REPORTER DURING A INGUINAL HERNIA REPAIR PROCEDURE, WHILE SUTURING THE THREAD BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706512 ↗
• MalfunctionMay 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING PERITONEAL SUTURE, THE TWO THREAD BROKE EASILY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281252 ↗
• MalfunctionMay 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING PERITONEAL SUTURE, THE TWO THREAD BROKE EASILY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281099 ↗
• MalfunctionApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN OPENING THE PACKAGE, THE TWO NEEDLES AND THREADS DETACHED WHEN THE NURSE CLAMPED IT WITH A NEEDLE HOLDER. IT WAS NOTED THAT IT OCCURRED TWICE CONSECUTIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183923 ↗
• MalfunctionApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN OPENING THE PACKAGE, THE TWO NEEDLES AND THREADS DETACHED WHEN THE NURSE CLAMPED IT WITH A NEEDLE HOLDER. IT WAS NOTED THAT IT OCCURRED TWICE CONSECUTIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183578 ↗
• MalfunctionJan 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE ON PERITONEUM CLOSURE BY SURGICAL INCISION, THE NEEDLE CAME OFF FROM THE POINT WHERE THE NEEDLE WAS INSERTED. A NEW PACKAGE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137774 ↗
• MalfunctionMar 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE WAS EASY TO BREAK.

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

  MAUDE report 13934406 ↗
• MalfunctionJan 5, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING PERITONEAL CONTINUOUS SUTURE IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE THREAD GOT BROKE HALFWAY. TO RESOLVE THE ISSUE, A NEW PACKET WAS TAKEN OUT AND SUTURED FROM THE SITE WHERE THE DEVICE GOT BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169361 ↗
• MalfunctionDec 6, 2021Break; Break

  ACCORDING TO THE REPORTER, WHILE CLOSING THE TRANSABDOMINAL PREPERITONEAL (TAPP), THE THREAD BROKE HALFWAY DURING STITCHING SEVERAL TIMES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12934015 ↗
• MalfunctionDec 20, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING A PERITONEUM DURING A LAPAROSCOPIC TRANSABDOMINAL PERITONEAL, FIVE SUTURE THREADS WERE BROKEN. ANOTHER SUTURE FROM A DIFFERENT BATCH WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9502129 ↗
• MalfunctionOct 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL (TAPP) REPAIR PROCEDURE, WHILE DOING PERITONEUM SUTURING, WHEN THE NEEDLE WAS APPLIED TO A SLIGHTLY THICKER ADIPOSE TISSUE, THE THREAD CAME OFF THE NEEDLE. THE NEEDLE FELL INTO THE TISSUE BUT WAS FOUND AND REMOVED. AFTER THAT, 3-0 DEVICES WAS TAKEN OUT AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200222 ↗
• MalfunctionJun 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, WHEN THEY PULLED OUT THE NEEDLE FROM THE PACKAGE, THE NEEDLE DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650396 ↗
• MalfunctionMar 6, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR TWO NEEDLES DETACHED, AND ONE SUTURE BROKE AT THE LOOP. SUTURES WERE DISENGAGED AT THE SITE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316209 ↗
• MalfunctionFeb 26, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PRE-PERITONEAL, THE DEVICE LOOP BROKE, AND WHEN THEY USED SECOND DEVICE, THE NEEDLE DETACHED. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7296366 ↗
• MalfunctionDec 15, 2017Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE¿S THREAD BROKE AT THE END OF THE PROCEDURE. THEY USED ANOTHER THREAD IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121636 ↗

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