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V-Loc 180 VLOCL0613Recalls & reported problems

Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant

All models of V-Loc 180 (61)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521131149), received between Apr 5, 2018 and Mar 30, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K091087); 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.

Most reported problems

Device problems

  • Break2
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A ONE-STAGE AUTOLOGOUS BREAST RECONSTRUCTION FOR RADICAL EXCISION OF LEFT BREAST CANCER, PROCEDURE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT TWO NEEDLE AND THREAD WERE SEPARATED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16647026 ↗
  • MalfunctionAug 13, 2019Break; Break

    ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, AT THE END OF SEWING THE SUBCUTICULAR LAYER, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8888616 ↗
  • MalfunctionApr 5, 2018Break; Break

    ACCORDING TO THE REPORTER PRIOR TO SUTURING ON A SHOULDER JOINT. WHEN THE DOCTOR TRIED TO HAVE THE NEEDLE THROUGH THE LOOP, THE LOOP BROKE AT THE ROOT OF IT. ANOTHER PRODUCT WAS USED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT HARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7399206 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.

  • Z-2919-2026 · Jun 24, 2026 · Open, Classified
    V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0

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Sources and updates

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