V-Loc 90 VLOCM0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20884521131610), received between Aug 6, 2017 and Nov 27, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, THERE WAS NEEDLE DETACHMENT. THE NEEDLE PULLED OFF THE STRAND WHILE SUTURING THE SKIN CLOSED. THE NEEDLE DID NOT FELL INTO THE PATIENT CAVITY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800975 ↗
• MalfunctionNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PERMANENT PACEMAKER INSERTION PROCEDURE, THREE SUTURES OPENED, AND ALL THREE BROKE WHILE SUTURING. WITH THE FOURTH SUTURE, THE NEEDLE DID NOT BREAK OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725661 ↗
• MalfunctionNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PERMANENT PACEMAKER INSERTION PROCEDURE, THREE SUTURES OPENED, AND ALL THREE BROKE WHILE SUTURING. WITH THE FOURTH SUTURE, THE NEEDLE DID NOT BREAK OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725504 ↗
• MalfunctionNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PERMANENT PACEMAKER INSERTION PROCEDURE, THREE SUTURES OPENED, AND ALL THREE BROKE WHILE SUTURING. WITH THE FOURTH SUTURE, THE NEEDLE DID NOT BREAK OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725383 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE, AT THE BEGINNING OF WOUND CLOSURE OR THE END OF THE PROCEDURAL STEP, THE NEEDLE AND THREAD BROKE OFF WHILE IN USE. ANOTHER SUTURE WAS OPENED WITH THE SAME LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813212 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE, AT THE BEGINNING OF WOUND CLOSURE OR THE END OF THE PROCEDURAL STEP, THE NEEDLE AND THREAD BROKE OFF WHILE IN USE. ANOTHER SUTURE WAS OPENED WITH THE SAME LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807243 ↗
• MalfunctionDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THREE NEEDLES POPPED OFF THE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 10964753 ↗
• MalfunctionNov 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN ORTHOPEDIC PROCEDURE, THE DEVICE HAD CAUSED SKIN REACTIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844751 ↗
• MalfunctionSep 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PORTACATH, THE NEEDLE BROKE OFF TWO STRANDS WHEN THE SURGEON WAS TRYING TO CLOSE THE SUBCUTANEOUS LAYER OF THE SKIN. THEY OPENED A NEW PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841822 ↗
• MalfunctionMar 2, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA REPAIR, WHILE BEING APPLIED FOR SKIN CLOSURE, THE DEVICE¿S THREAD BROKE, AND WHEN THE SURGEON WAS CLOSING THE SKIN THE NEEDLE PULLED OFF THE STRAND. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311244 ↗
• MalfunctionDec 22, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, INTRADERMAL SUTURE CLOSURE WAS THE TECHNIQUE USED. WHEN CLOSING THE PATIENT'S SKIN BY INTRADERMAL SUTURING, THE DISTAL CLOSING LOOP OF THE DEVICE DETACHED ITSELF AND THE SUTURE COULD NOT BE PERFORMED. A NEW SUTURE WAS USED WITH THE SAME LOT NUMBER WITHOUT A PROBLEM. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7145027 ↗
• MalfunctionDec 4, 2017Degraded; Degraded

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE HAD BEEN ERODING, CAUSING THE PATIENT¿S SKIN NOT TO HEAL. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7080655 ↗
• MalfunctionAug 6, 2017Break; Break

  ACCORDING TO THE REPORTER, THE LOOPS OF THE DEVICE CAME LOOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769920 ↗

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