V-Loc VLOCN006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521068827), received between Jun 14, 2017 and Nov 21, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 16, 2026.

Recalls naming this device

1. Sep 28, 2022Open, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE FROM THE INSTRUMENT BROKE OFF AND BECAME STUCK IN THE VAGINAL CUFF. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE. THE NEEDLE COULD NOT BE RETRIEVED AND WAS LEFT IN THE VAGINAL CUFF.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 23620575 ↗
• MalfunctionAug 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS WITH HIATAL HERNIA, THE SURGEON WAS SUTURING WITHOUT TENSION AND THE NEEDLE BROKE IN HALF INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE DISENGAGED NEEDLE USING A GRASPER. A NEW RELOAD WAS OPENED AND USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143104 ↗
• MalfunctionAug 1, 2022Break; No Device Output; Detachment of Device or Device Component; Break; No Device Output; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y PLUS HIATAL HERNIA PROCEDURE, WHILE PERFORMING THE HIATAL HERNIA, THE SURGEON FELT NO PRESSURE WHILE SUTURING AND THE NEEDLE SPLIT IN HALF AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO LOCATE THE NEEDLE PIECES WITH FLAT GRASPERS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140055 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  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 9519698 ↗
• InjuryNov 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HIATAL HERNIA PROCEDURE, THE SURGEON PASSED THE NEEDLE THRU THE TISSUE ONCE WITHOUT ANY ISSUES. DURING THE SECOND PASS THRU THE TISSUE, THE NEEDLE CAME OFF THE INSTRUMENT, FELL INSIDE THE CAVITY AND THE SUTURE STRAND BROKE OFF THE NEEDLE. IT WAS RETRIEVED USING GRASPERS. THIS LEAD TO TYING TO FIND THE NEEDLE INSIDE THE CAVITY THAT TOOK OVER 30 MINUTES TO FIND. NEW DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 8034135 ↗
• MalfunctionDec 5, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAP NISSEN, WHILE SUTURING THE GASTRIC WRAP TOGETHER, THE THREAD OF THE DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085415 ↗
• MalfunctionAug 23, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAP NISSEN, WHILE SUTURING THE GASTRIC WRAP TOGETHER, THE THREAD OF THE DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813823 ↗
• MalfunctionJun 14, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA REPAIR, WHILE SUTURING THE PERITONEUM, THE NEEDLE WOULD NOT ATTACH TO THE HANDLE AND JUST SLIPPED OUT. WHEN INSERTED INTO THE PATIENT CAVITY IT FELL OFF THE ENDOSTITCH. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6641404 ↗

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.