V-Loc 180 VLOCA204LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521068117), received between Aug 17, 2017 and May 9, 2022 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VAGINAL HYSTERECTOMY, AT CLOSURE OF VAGINAL CUFF, THE DEVICE WAS NOT CLICKING RIGHT. THE JAWS WERE OPENED AND FOUND THERE WAS NO SUTURE OR NEEDLE. THE SURGEON LOCATED HALF OF THE NEEDLE. THE OTHER HALF WAS STILL LODGED IN THE VAGINAL CUFF, WHICH WAS LOCATED AND REMOVED THROUGH THE USE OF X-RAY. THE SURGICAL TIME WAS EXTENDED BY AT LEAST 30 MINUTES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14342779 ↗
• InjuryOct 14, 2019Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF THE VAGINAL CUFF ON A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE BROKE OFF AND X-RAY WAS TAKEN TO FIND THE TIP OF THE NEEDLE. IT WAS ALSO STATED THAT THE DEVICE WAS DIFFICULT TO UNLOAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9186475 ↗
• MalfunctionJun 22, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE THE DEVICE WAS BEING APPLIED TO THE VAGINAL CUFF, THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED USING LAPAROSCOPIC GRASPER. NEW NEEDLE WAS RELOADED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7629586 ↗
• MalfunctionAug 17, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY, THE DEVICE NEEDLE CAME OUT OF THE ENDOSTITCH WHILE OVERSEWING THE STAPLE LINE. THE NEEDLE FELL OUT OF ENDOSTITCH AND WAS RETRIEVED WITH THE GRASPER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY HAS BEEN NOTED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6801882 ↗

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