V-Loc 180 VLOCA004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521068087), received between Jul 14, 2017 and Jan 13, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL HYSTERECTOMY, THE NEEDLE DISENGAGED INTO THE PATIENT'S CAVITY. THE SURGEON LEFT THE BROKEN PIECE OF THE NEEDLE IN THE CAVITY. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21137686 ↗
• MalfunctionJul 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTROPATHY ON A DOG, WHEN REUSING A DISPOSABLE DEVICE, THE NEEDLE CRACKED IN HALF. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14993699 ↗
• MalfunctionJul 18, 2018Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, DURING THE SUTURING THE VAGINAL CUFF ON A VAGINAL HYSTERECTOMY, THE NEEDLE DISENGAGED AND FELL INTO PATIENT CAVITY. THE NEEDLE FROM THE RELOAD FELL IN AND INFORMATION ABOUT RETRIEVAL WAS STILL UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7700885 ↗
• MalfunctionFeb 1, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE INSIDE THE PATIENT'S BODY AND THEY WERE ABLE TO RECOVER IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7233855 ↗
• MalfunctionJul 14, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE, NEEDLE SPONTANEOUSLY DROPPED DURING CUFF CLOSURE AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS SUCCESSFULLY REMOVED WITH A LAP GRASPER. TWO (2) ADDITIONAL NEW RELOADS WERE USED ON THE SAME ENDOSTITCH WITHOUT ISSUE. THERE WAS NO PATIENT INJURY INVOLVED REGARDING THE EVENT. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6715989 ↗

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