V-Loc VLOCN206LRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521068834), received between Mar 8, 2022 and Feb 17, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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-0201-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, TWO DEVICES HAD THEIR NEEDLES BREAKING OFF. AN X-RAY WAS PERFORMED TO CONFIRM THE LOCATION OF THE BROKEN PIECES.

  Patient problems: Foreign Body In Patient; Insufficient Information; Unintended Radiation Exposure

  MAUDE report 24373396 ↗
• InjuryFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, TWO DEVICES HAD THEIR NEEDLES BREAKING OFF. AN X-RAY WAS PERFORMED TO CONFIRM THE LOCATION OF THE BROKEN PIECES.

  Patient problems: Foreign Body In Patient; Insufficient Information; Unintended Radiation Exposure

  MAUDE report 24373363 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, TWO DEVICES HAD THEIR NEEDLES BREAKING OFF. AN X-RAY WAS PERFORMED TO CONFIRM THE LOCATION OF THE BROKEN PIECES.

  Patient problems: Insufficient Information

  MAUDE report 24373318 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, TWO DEVICES HAD THEIR NEEDLES BREAKING OFF. AN X-RAY WAS PERFORMED TO CONFIRM THE LOCATION OF THE BROKEN PIECES.

  Patient problems: Insufficient Information

  MAUDE report 24373301 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, TWO DEVICES HAD THEIR NEEDLES BREAKING OFF. AN X-RAY WAS PERFORMED TO CONFIRM THE LOCATION OF THE BROKEN PIECES.

  Patient problems: Insufficient Information

  MAUDE report 24373160 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, TWO DEVICES HAD THEIR NEEDLES BREAKING OFF. AN X-RAY WAS PERFORMED TO CONFIRM THE LOCATION OF THE BROKEN PIECES.

  Patient problems: Insufficient Information

  MAUDE report 24373135 ↗
• MalfunctionMay 5, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE THE SURGEON WAS USING THE NON-ABSORBABLE SUTURE TO SUTURE THE DEFECT, WHEN THE SUTURE WAS SINCHED THROUGH THE LOOP, THE LOOP SNAPPED. THE ISSUE HAPPENED FIVE TIMES. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE. SINCE THE LOOP OF THE SUTURE KEPT SNAPPING, THE SURGEON HAD TO WAIT FOR A NEW SUTURE TO BE LOADED ONTO THE HANDLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED, AND SUTURES FROM A DIFFERENT BOX WITH THE SAME LOT NUMBER WERE TRIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958796 ↗
• MalfunctionMay 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE THE SURGEON WAS USING THE NON-ABSORBABLE SUTURE TO SUTURE THE DEFECT, WHEN THE SUTURE WAS SINCHED THROUGH THE LOOP, THE LOOP SNAPPED. THE ISSUE HAPPENED FIVE TIMES. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE. SINCE THE LOOP OF THE SUTURE KEPT SNAPPING, THE SURGEON HAD TO WAIT FOR A NEW SUTURE TO BE LOADED ONTO THE HANDLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED, AND SUTURES FROM A DIFFERENT BOX WITH THE SAME LOT NUMBER WERE TRIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955880 ↗
• MalfunctionMay 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE THE SURGEON WAS USING THE NON-ABSORBABLE SUTURE TO SUTURE THE DEFECT, WHEN THE SUTURE WAS CINCHED THROUGH THE LOOP, THE LOOP SNAPPED. THE ISSUE HAPPENED FIVE TIMES. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE. SINCE THE LOOP OF THE SUTURE KEPT SNAPPING, THE SURGEON HAD TO WAIT FOR A NEW SUTURE TO BE LOADED ONTO THE HANDLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED, AND SUTURES FROM A DIFFERENT BOX WITH THE SAME LOT NUMBER WERE TRIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955879 ↗
• MalfunctionMay 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE THE SURGEON WAS USING THE NON-ABSORBABLE SUTURE TO SUTURE THE DEFECT, WHEN THE SUTURE WAS SINCHED THROUGH THE LOOP, THE LOOP SNAPPED. THE ISSUE HAPPENED FIVE TIMES. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE. SINCE THE LOOP OF THE SUTURE KEPT SNAPPING, THE SURGEON HAD TO WAIT FOR A NEW SUTURE TO BE LOADED ONTO THE HANDLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED, AND SUTURES FROM A DIFFERENT BOX WITH THE SAME LOT NUMBER WERE TRIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955871 ↗
• MalfunctionMay 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE THE SURGEON WAS USING THE NON-ABSORBABLE SUTURE TO SUTURE THE DEFECT, WHEN THE SUTURE WAS SINCHED THROUGH THE LOOP, THE LOOP SNAPPED. THE ISSUE HAPPENED FIVE TIMES. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE. SINCE THE LOOP OF THE SUTURE KEPT SNAPPING, THE SURGEON HAD TO WAIT FOR A NEW SUTURE TO BE LOADED ONTO THE HANDLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED, AND SUTURES FROM A DIFFERENT BOX WITH THE SAME LOT NUMBER WERE TRIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955868 ↗
• MalfunctionFeb 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE, THE NEEDLE BROKE IN HALF WHILE SUTURING THE HIATUS AND FELL INTO THE PATIENT'S CAVITY. THE BROKEN HALF OF THE NEEDLE WAS RETRIEVED USING A GRASPER. ANOTHER SUTURING DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807118 ↗
• MalfunctionJul 24, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA, THE NEEDLE BROKE IN HALF. THE SURGEON PULLED THE BROKEN NEEDLE OUT AND CLOSED WITH A NEW SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378518 ↗
• MalfunctionMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN PROCEDURE. THE NEEDLE FELL OFF THE HANDLE 3 TIMES WHILE OPERATING. THE NEEDLE FELL IN THE PATIENT'S CAVITY AND WAS RETRIEVED VIA GRASPERS. THE SURGEON LOADED ANOTHER NEEDLE TO THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994620 ↗
• MalfunctionMay 24, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC FUNDOPLICATION NISSEN, THE SUTURE TIP WAS BREAKING OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993995 ↗
• MalfunctionMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN PROCEDURE, THE NEEDLE FELL OFF THE HANDLE THREE TIMES WHILE OPERATING. THE NEEDLE FELL IN THE PATIENT'S CAVITY AND WAS RETRIEVED VIA GRASPERS. THE SURGEON LOADED ANOTHER NEEDLE TO THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993652 ↗
• MalfunctionMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN PROCEDURE, THE NEEDLE FELL OFF THE HANDLE THREE TIMES WHILE OPERATING. THE NEEDLE FELL IN THE PATIENT'S CAVITY AND WAS RETRIEVED VIA GRASPERS. THE SURGEON LOADED ANOTHER NEEDLE TO THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992324 ↗
• InjuryMar 8, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SEWING THE STOMACH IN A LAPAROSCOPIC GASTRIC BYPASS, THE NEEDLE BROKE IN HALF AND FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED, HALF OF THE NEEDLE WAS RETRIEVED BY A LAPAROSCOPIC GRASPER AND THE OTHER HALF IS STILL INSIDE PATIENT. THE SURGICAL PROCEDURE GOT EXTENDED FOR MORE THAN THIRTY MINUTES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13691133 ↗

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.