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V-Loc 180 VLOCL0336Recalls & reported problems

Covidien LP · Absorbable Wound Closure Device,GS-21,1x Green Strand · Class 2 · Implant

All models of V-Loc 180 (61)

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

Quick summary

This Covidien V-Loc 180 is an absorbable wound-closure suture. Its 96 reports mostly describe the suture breaking during closure, and some describe the needle detaching from the thread in cesarean sections, myomectomies and other operations, with surgeons replacing the suture to finish. The reports include 3 injuries and no deaths. Reports rose to 26 in the last 12 months from 14 in the 12 months before. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
97
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10884521131026), received between Oct 31, 2017 and Sep 17, 2026 — classified as 3 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Break” (80 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 2 reportsFeb 2024: 1 reportsMar 2024: 5 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 7 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 3 reportsJun 2025: 4 reportsJul 2025: 1 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 2 reportsDec 2025: 5 reportsJan 2026: 3 reportsFeb 2026: 7 reportsMar 2026: 2 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 3 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break80
  • Detachment of Device or Device Component20
  • Patient-Device Incompatibility3
  • Unraveled Material3
  • Product Quality Problem2
  • Adverse Event Without Identified Device or Use Problem1
  • Component Missing1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions74
  • Insufficient Information13
  • No Consequences Or Impact To Patient3
  • No Known Impact Or Consequence To Patient3
  • Wound Dehiscence3
  • No Code Available2
  • Discomfort1
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 17, 2026Break; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50812720 ↗
  • MalfunctionSep 17, 2026Break; Detachment of Device or Device Component

    According to the reporter, in an open joint replacement surgery, while suturing the joint capsule, two sutures from the same lot broke and the needle detached from the thread. Another suture from another manufacturer was used to resolve the issue. There was no patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50805282 ↗
  • MalfunctionJul 9, 2026Break

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE BROKE WHILE SUTURING THE WOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25758566 ↗
  • MalfunctionJun 22, 2026Break

    ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION, AT THE TIME OF SUTURING THE MYOMETRIUM, THE TIP OF THE NEEDLE BROKE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. ANOTHER NEW SUTURE USED WAS WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25587922 ↗
  • MalfunctionJun 12, 2026Break

    ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC MYOMECTOMY AND RIGHT MESOSALPINX CYSTECTOMY, AFTER REMOVAL OF THE MYOMA, AN ABSORBABLE BARBED SUTURE WAS USED TO CLOSE THE UTERINE INCISION. AT APPROXIMATELY THE 6TH STITCH, THE SUTURE BROKE. THE SUTURE WAS IMMEDIATELY REPLACED WITH A NEW ABSORBABLE SUTURE TO CONTINUE SUTURING, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PROCEDURE TIME WAS PROLONGED BY ABOUT 3 MINUTES. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25481658 ↗
  • MalfunctionJun 12, 2026Break

    ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC MYOMECTOMY AND AND PELVIC ADHESION LYSIS, AFTER REMOVAL OF THE MYOMA, AN ABSORBABLE BARBED SUTURE WAS USED TO CLOSE THE UTERINE INCISION. AT APPROXIMATELY THE 8TH STITCH, THE SUTURE BROKE. ANOTHER SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS THEN USED TO CONTINUE THE SUTURING. THE PROCEDURE TIME WAS PROLONGED BY ABOUT 3 MINUTES. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25481594 ↗
  • MalfunctionMay 19, 2026Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING AN OPEN BONE TUMOR RESECTION SURGERY, WHEN SUTURING THE FASCIAL LAYER OF THE INCISION, BOTH THE NEEDLE AND THREAD BROKE. THE SUTURING WAS COMPLETED BY REPLACING WITH A NEW SUTURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25224769 ↗
  • MalfunctionApr 2, 2026Break

    ACCORDING TO THE REPORTER, IN AN OPEN LIVER CANCER RESECTION, DURING FASCIAL SHEATH CLOSURE AFTER ABDOMINAL CLOSURE, THE THREAD OF THE SUTURE INSTANTLY BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24762468 ↗
  • MalfunctionMar 13, 2026Break

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24594092 ↗
  • MalfunctionMar 2, 2026Break

    ACCORDING TO THE REPORTER, DURING A MYOMECTOMY, THE SUTURE BROKE AFTER ONLY ONE STITCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: Insufficient Information

    MAUDE report 24478774 ↗
  • MalfunctionFeb 18, 2026Break

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, A TOTAL OF 16 SUTURES BROKE DURING USE. A NEW SUTURE FROM A DIFFERENT LOT WAS TRIED AND USED TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24384184 ↗
  • MalfunctionFeb 18, 2026Break

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, A TOTAL OF 16 SUTURES BROKE DURING USE. A NEW SUTURE FROM A DIFFERENT LOT WAS TRIED AND USED TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24384143 ↗
  • MalfunctionFeb 18, 2026Break

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, A TOTAL OF 16 SUTURES BROKE DURING USE. A NEW SUTURE FROM A DIFFERENT LOT WAS TRIED AND USED TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24384140 ↗
  • MalfunctionFeb 18, 2026Break

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, A TOTAL OF 16 SUTURES BROKE DURING USE. A NEW SUTURE FROM A DIFFERENT LOT WAS TRIED AND USED TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24384131 ↗
  • MalfunctionFeb 18, 2026Break

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, A TOTAL OF 16 SUTURES BROKE DURING USE. A NEW SUTURE FROM A DIFFERENT LOT WAS TRIED AND USED TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24384075 ↗
  • MalfunctionFeb 18, 2026Break

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC MYOMECTOMY SUTURING, THE NEEDLE BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24381636 ↗
  • MalfunctionFeb 3, 2026Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING SUTURING, THE SUTURE WAS DAMAGED AT THE SWAGE. ANOTHER NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24246451 ↗
  • MalfunctionJan 5, 2026Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, IN CLOSING THE UTERUS, AFTER PLACING THE FIRST STITCH, THE NEEDLE AND SUTURE WERE DETACHED. THE PREVIOUSLY PLACED SUTURE WAS IMMEDIATELY REMOVED, AND A NEW SUTURE WAS USED. IT WAS NOTED THAT THE PROCEDURE TIME WAS PROLONGED.

    Patient problems: Insufficient Information

    MAUDE report 23965538 ↗
  • MalfunctionJan 2, 2026Break

    ACCORDING TO THE REPORTER, IN AN OPEN LIVER CANCER SURGERY, WHILE SUTURING FOR ABDOMINAL CLOSURE, THE THREAD OF TWO SUTURES BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE SUTURING. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23952728 ↗
  • MalfunctionJan 2, 2026Break

    ACCORDING TO THE REPORTER, IN AN OPEN LIVER CANCER SURGERY, WHILE SUTURING FOR ABDOMINAL CLOSURE, THE THREAD OF TWO SUTURES BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE SUTURING. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23952725 ↗
  • MalfunctionDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A HIP REPLACEMENT, THE SUTURE BROKE. ANOTHER SUTURE WAS USED BUT THE SAME ISSUE OCCURRED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23851628 ↗
  • MalfunctionDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A HIP REPLACEMENT, THE SUTURE THREAD DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED BUT THE SAME ISSUE OCCURRED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23851576 ↗
  • MalfunctionDec 15, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY, WHILE ON SUTURING PROCESS, THE NEEDLE OF THE SUTURE WAS KINKED, AND A SUTURE BREAKAGE WAS ALSO OBSERVED. ANOTHER SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS DELAYED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23811891 ↗
  • MalfunctionDec 11, 2025Break; Break

    ACCORDING TO THE REPORTER, DURING AN OPEN BONE TUMOR SURGERY, WHILE SUTURING THE INCISION, THE THREAD BROKE INSTANTLY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23782506 ↗
  • MalfunctionDec 11, 2025Break; Break

    ACCORDING TO THE REPORTER, DURING AN OPEN BONE TUMOR SURGERY, WHILE SUTURING THE INCISION, THE THREAD BROKE INSTANTLY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23782504 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page