V-Loc 90 VLOCM0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521131620), received between Sep 6, 2017 and Jul 2, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY WITH ENDOMETRIOSIS EXCISION, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING AFTER THE PATIENT INCISION, AND THE NEEDLE FELL INTO THE PATIENT CAVITY. THE SURGICAL TIME WAS EXTENDED BY ONE MINUTE WHILE THE NEEDLE WAS LOCATED AND RETRIEVED USING LAPAROSCOPIC GRASPERS. A NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387365 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SPINAL CORD STIMULATOR, HALFWAY THROUGH SUTURING, THE NEEDLE POPPED OFF. THE SURGEON HAD TO START OVER USING A NEW SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

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

  MAUDE report 18853042 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SPINAL CORD STIMULATOR, HALFWAY THROUGH SUTURING, THE NEEDLE POPPED OFF. THE SURGEON HAD TO START OVER USING A NEW SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

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

  MAUDE report 18853028 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SPINAL CORD STIMULATOR, HALFWAY THROUGH SUTURING, THE NEEDLE POPPED OFF. THE SURGEON HAD TO START OVER USING A NEW SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

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

  MAUDE report 18853023 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SPINAL CORD STIMULATION PROCEDURE, HALFWAY THROUGH CLOSING THE INCISION, THE NEEDLE POPPED OFF. THE SURGEON HAD TO START OVER USING A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853015 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SPINAL CORD STIMULATOR, HALFWAY THROUGH SUTURING, THE NEEDLE POPPED OFF. THE SURGEON HAD TO START OVER USING A NEW SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

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

  MAUDE report 18853010 ↗
• MalfunctionNov 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE AND THE THREAD BROKE. THE NEEDLE "POPPED OFF" THE STRAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8065236 ↗
• MalfunctionOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE FROM THE NEEDLE WHEN REMOVED FROM THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8013883 ↗
• MalfunctionSep 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN PROCEDURE. THE SUTURE BROKE. THE THREAD BROKE FROM THE NEEDLE. THERE WAS MORE THAN ONE DEFECTIVE DEVICE INVOLVED, NOT ALL OCCURRING DURING THE SAME CASE. TO CORRECT THE ISSUE, ANOTHER SUTURE WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6845240 ↗

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