V-Loc 180 VLOCA306LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521068155), received between Jun 7, 2019 and Dec 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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-0200-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2019Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY HIATUS REPAIR, WHILE REPOSITIONING STOMACH AFTER THE PROCEDURE, SURGEON ATTEMPTED TO LOAD THE DEVICE BUT WAS NOT SUCCESSFUL. IT WAS ALSO REPORTED THAT THE SUTURE FELL OFF INTO PATIENT'S ABDOMEN AND WAS RETRIEVED BY GRASPERS. SURGEON REMOVED THE SUTURE IN ORDER TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE BUT SURGEON EXPERIENCED DIFFICULTY IN UNLOADING THE DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414437 ↗
• MalfunctionJun 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN CLOSING MESENTERIC WINDOW 2 SUTURES FELL OF FROM THE POINT OF ATTACHMENT IN THE DEVICE. A THIRD RELOAD WAS USED TO COMPLETE THE CASE, THE SAME HANDLE WAS USED THROUGHOUT THE PROCEDURE. THERE IS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679986 ↗

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-0201-2023 · Sep 28, 2022 · Open, Classified
  Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L