V-Loc VLOCN208LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521073777), received between May 18, 2021 and Jan 24, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE BECAME SEPARATED UNINTENTIONALLY FROM THE SUTURE; BOTH TIMES HAD BEEN WITH THE SAME SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 21229740 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE BECAME SEPARATED UNINTENTIONALLY FROM THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 21229732 ↗
• InjuryJul 7, 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 LAP HIATAL HERNIA SURGERY, THE NEEDLE BROKE WITHOUT TENSION AND BECAME LODGED IN THE CRUS. IT WAS NOT ABLE TO BE FOUND AND LEFT IN THE BODY. SURGICAL TIME WAS EXTENDED BY AT LEAST THIRTY MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17283860 ↗
• InjuryMay 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN CLOSING THE VAGINAL CUFF DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SURGEON WAS ABLE TO THROW 2-3 THROWS OF THE SUTURE BEFORE THE NEEDLE FELL OFF INSIDE THE PATIENT. WHEN SURGEON REALIZED THE NEEDLE HAD FALLEN OFF, THE SURGEON HAD TO X-RAY THE PATIENT IN THE ROOM, RE-OPENED THE VAGINAL CUFF TO FIND THE NEEDLE AND THEN NEVER FOUND IT. IT IS STILL INSIDE THE PATIENT AND THE PROCEDURE WAS EXTENDED FOR OVER AN HOUR.

  Patient problems: Foreign Body In Patient; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 11840723 ↗

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.