V-Loc VLOCN0804Recalls & reported problems
Covidien LP · PBT Non Absorbable Wound Closure Device, CV-23, 1x Blue Strand · Class 2 · Implant
All models of V-Loc (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521214712), received between Oct 3, 2023 and Sep 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED DISTAL GASTRECTOMY PROCEDURE, WHILE SUTURING THE PETERSEN'S DEFECT, THE CENTRAL PART OF THE SUTURE WAS DAMAGED. THE SUTURE REMAINED IN THE TISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20257205 ↗MalfunctionOct 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DISTAL GASTRECTOMY PROCEDURE, WHEN IT WAS TRIED TO CLOSE THE PETERSEN DEFECT BY HOLDING IT WITH A NEEDLE HOLDER, THE THREAD CAME OUT OF THE NEEDLE. THE THREAD DROPPED INTO THE PATIENT'S ABDOMINAL CAVITY, BUT IT WAS IMMEDIATELY PICKED UP AND PUT OUTSIDE. A NEW SUTURE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862965 ↗
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- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
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- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
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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