V-Loc VLOCN1126Recalls & reported problems
Covidien LP · PBT Non Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521127927), received between Dec 15, 2017 and Feb 22, 2026 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (8 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break8
- Detachment of Device or Device Component1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Code Available2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROCEDURE FOR A SMALL RIGHT INGUINAL HERNIA, WHEN THE BARBED SUTURE WAS BEING APPLIED DURING CLOSURE OF THE PERITONEUM AND DURING INSERTION INTO THE PATIENT, THE NEEDLE DETACHED FROM THE THREAD. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24410966 ↗MalfunctionMay 9, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA REPAIR PROCEDURE, WHEN SUTURING THE MESH IN TISSUE USING THE BARBED SUTURE, THE THREAD BROKE ON THREE BARBED SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281272 ↗MalfunctionMay 9, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA REPAIR PROCEDURE, WHEN SUTURING THE MESH IN TISSUE USING THE BARBED SUTURE, THE THREAD BROKE ON THREE BARBED SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281270 ↗MalfunctionMay 9, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA REPAIR PROCEDURE, WHEN SUTURING THE MESH IN TISSUE USING THE BARBED SUTURE, THE THREAD BROKE ON THREE BARBED SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281073 ↗MalfunctionApr 10, 2024Break; Material Frayed; Break; Material Frayed
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE FOR DIASTASIS OF THE ABDOMINAL RECTUS, A RESECTION WAS PERFORMED, AND WHEN CLOSING AT THE PERITONEUM, THE THREAD BROKE WITHOUT THE SURGEON MAKING ANY EFFORT. IT WAS NOTED THAT THERE WERE UNRAVELED FILAMENTS IN THE SUTURE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19079771 ↗MalfunctionSep 7, 2022Break; Break
ACCORDING TO THE REPORTER, ON AN OPEN ABDOMINAL HERNIA, DURING THE TRACTION OF THREAD WHILE USING THE CONTINUOUS SUTURE TECHNIQUE, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15374931 ↗MalfunctionAug 31, 2022Break; Break
ACCORDING TO THE REPORTER, DURING OPEN ABDOMINOPLASTY AFTER BARIATRIC SURGERY, IN THE RECTO-ABDOMINAL MUSCLE PLICATION, THE THREAD OF THE THREE SUTURES BROKE AT THE FIRST TRACTION. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15330065 ↗InjuryFeb 5, 2020Break; Break
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR, WHILE BEING APPLIED ON THE MUSCULAR ABDOMINAL WALL, FOUR THREADS BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY 1 HOUR DUE TO THE REPORTED CONDITION.
Patient problems: No Code Available
MAUDE report 9670872 ↗InjuryDec 15, 2017Break; Break
ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A LAPAROSCOPIC TOTAL EXTRAPERITONEAL PROCEDURE ,ON FASCIA CLOSURE, THE THREAD OF THE DEVICE BROKE AFTER THE PROCEDURE. A REOPERATION WAS NEEDED, THE HOSPITALIZATION WAS PROLONGED FOR ONE DAY. NO PATIENT INJURY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7123232 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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