V-Loc VLOCN0615Recalls & reported problems
Covidien LP · PBT Non Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521135291), received between Dec 5, 2017 and Dec 19, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (18 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break18
- Detachment of Device or Device Component1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information6
- Discomfort1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, THE LOOP OF THE SUTURE WAS FOUND TO BE BROKEN. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849318 ↗MalfunctionMar 13, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL HYSTERECTOMY PROCEDURE, THE TWO SUTURES WERE CUT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599310 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT DURING A SUTURING HERNIOPLASTY PROCEDURE USING THE DEVICE, THE TWO SUTURES BROKE. THE BREAKAGE OCCURRED WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584053 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT DURING A SUTURING PROCEDURE USING THE DEVICE, THE SUTURES BROKE. THE BREAKAGE OCCURRED WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584029 ↗MalfunctionMar 10, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO SUTURES WERE CUT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567311 ↗MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT DURING A SUTURING PROCEDURE USING THE DEVICE, THE SUTURE BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. IT OCCURRED ON TWO SUTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21561992 ↗MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT DURING A SUTURING PROCEDURE USING THE DEVICE, THE SUTURE BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. IT OCCURRED ON TWO SUTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21561987 ↗MalfunctionSep 17, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE OF THE FIVE DEVICES BROKE.
Patient problems: Insufficient Information
MAUDE report 20236470 ↗MalfunctionSep 17, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE OF THE FIVE DEVICES BROKE.
Patient problems: Insufficient Information
MAUDE report 20236455 ↗MalfunctionSep 17, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE OF THE FIVE DEVICES BROKE.
Patient problems: Insufficient Information
MAUDE report 20236444 ↗MalfunctionSep 17, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE OF THE FIVE DEVICES BROKE.
Patient problems: Insufficient Information
MAUDE report 20236398 ↗MalfunctionSep 17, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE OF THE FIVE DEVICES BROKE.
Patient problems: Insufficient Information
MAUDE report 20236388 ↗MalfunctionApr 24, 2024Break; Break
ACCORDING TO THE CLINICAL STUDY, DURING AN OPEN UMBILICAL HERNIOPLASTY, THE STRAND WAS BROKEN TWICE, AND IT DID NOT APPEAR TO HAVE THE SUPPORT NEEDED TO SUTURE THE TISSUE. IT WAS NOTED THAT THE SUTURE REMAINED IN THE PHYSICIAN'S HAND NOT IN THE PATIENT. ANOTHER PACKAGE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19177489 ↗MalfunctionJan 29, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATUS HERNIAL REPAIR, UPON SUTURING THE DIAPHRAGMATIC PILLARS, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18602501 ↗MalfunctionDec 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, WHEN THE SURGEON WAS HANDED A SUTURE TO CLOSE THE VAGINAL CUFF, A NON-ABSORBABLE SUTURE WAS GIVEN INSTEAD OF AN ABSORBABLE ONE. THE PATIENT WAS EXPERIENCING DISCOMFORT.
Patient problems: Discomfort
MAUDE report 18340177 ↗MalfunctionJul 3, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF PASSING THE THREAD AND MAKING A KNOT, THE THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 17247098 ↗MalfunctionJun 1, 2023Break; Break
ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC HERNIA SURGERY, THE THREAD OF THREE SUTURES BROKE. 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 17043728 ↗MalfunctionMay 23, 2023Break; Break
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, AT THE BEGINNING, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE I SSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16983686 ↗MalfunctionJan 25, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA REPAIR, WHILE CLOSING THE DEFECT AND SECURING THE HERNIA MESH . A TOTAL OF THREE SUTURE THREADS SNAPPED AFTER TWO TO THREE PASSES THROUGH THE TISSUE WHILE USING NORMAL RUNNING STITCH. THE SURGEON REMOVED THE BROKEN PIECES OF THREAD AND USED A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13351598 ↗MalfunctionDec 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE OVER SEWING THE STOMACH WITH THE DEVICE, THE SUTURE DETACHED WITHOUT THE SURGEON USING ANY PRESSURE OR TENSION ON THE SUTURE. ANOTHER DEVICE WAS OPENED AND THE SAME PROBLEM OCCURRED. PATIENT WAS NOT INJURED OR JEOPARDIZED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7082493 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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