V-Loc VLOCN308LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521073814), received between Mar 2, 2018 and Mar 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS PROCEDURE, WHILE SUTURING WITH AN INSTRUMENT, WHEN PASSING THROUGH THE LOOP, ¿IT OPENED UP AS THE PULLED IT DOWN TO LOCK¿. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311232 ↗

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.