V-Loc VLOCN008LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521073609), received between Apr 28, 2017 and Sep 17, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

1 other recall cover devices cleared under the same FDA submission (K111442); 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.

Recalls naming this device

1. Sep 28, 2022Class IIOpen, Classified

   Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

   Z-0201-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  It was reported that during a laparoscopic inguinal hernia repair procedure, the needle broke. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804558 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BARIATRIC SADI (SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS WITH SLEEVE GASTRECTOMY) LAPAROSCOPIC PROCEDURE, WHILE CLOSING A HIATAL HERNIA, THE SUTURE DETACHED FROM THE METAL CRIMP AT THE TRANSITION PIECE FROM THE SILK TO HANDLE ON THE RELOAD DURING NORMAL SUTURING MOTION. THERE WAS NO TENSION APPLIED AT THE TIME OF DETACHMENT, AND THE SUTURE SIMPLY FELL OUT. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853757 ↗
• InjuryOct 10, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE, THE SUTURE NEEDLE BROKE INTO TWO PIECES INSIDE THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE PIECES, AND AN X-RAY CONFIRMED THAT NO OBJECTS WERE RETAINED. AS A RESULT, THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO A PRODUCT PROBLEM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17906272 ↗
• MalfunctionJul 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, THE NEEDLE BROKE. THE SURGEON RETRIEVED ALL THE NEEDLE PIECES AND USED A COMPETITOR'S SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992493 ↗
• MalfunctionApr 28, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A ROUX-EN-Y GASTRIC BYPASS. THE LOOP AT THE END OF THE SUTURE STRAND CAME OPEN/UNDONE DURING THE LAST STEP OF THE PROCEDURE. TO CORRECT THE ISSUE, THE SUTURE STRAND WAS REMOVED AND REPLACED. NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6531804 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111442. One submission often covers many models, so check the product and lot details in each record.

• Z-0200-2023 · Sep 28, 2022 · Open, Classified
  Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.