V-Loc 180 VLOCL0316Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Covidien V-Loc 180 is a barbed absorbable wound-closure suture. Its 378 reports mostly describe sutures breaking or needles detaching during procedures. The reports include 20 injuries and no deaths. There is 1 open recall, started in June 2026, because sterile packaging may have a tear that could contaminate the sutures.
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
- 376
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 376 adverse event reports that list this exact device (DI 10884521131316), received between Oct 4, 2017 and Sep 2, 2026 — classified as 20 injuries, 356 malfunctions.
The most frequently reported specific device problem is “Break” (195 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 24, 2026Class IIOpen, Classified
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Z-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Break195
- Detachment of Device or Device Component182
- Insufficient Device Problem Information26
- Unraveled Material10
- Adverse Event Without Identified Device or Use Problem3
- Component Missing2
- Material Twisted/Bent2
- Patient-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions299
- Insufficient Information66
- No Consequences Or Impact To Patient23
- No Known Impact Or Consequence To Patient10
- Unspecified Tissue Injury7
- Tissue Breakdown5
- Hemorrhage/Blood Loss/Bleeding4
- Unintended Radiation Exposure4
Recent adverse event reports
The 25 most recent of 376 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573538 ↗MalfunctionJul 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065977 ↗MalfunctionMay 15, 2026Break
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RESECTION OF CERVICAL TUMOR, WHEN SUTURING THE VAGINAL CUFF, THE SUTURE BROKE AND COULD NOT BE USED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25192461 ↗MalfunctionMay 8, 2026Break
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SURGEON ENCOUNTERED BREAKAGE OF A BARBED SUTURE WHILE SUTURING THE UTERINE MUSCLE LAYER. THE BROKEN BARBED SUTURE WAS IMMEDIATELY REMOVED. THE CIRCULATING NURSE AND THE SCRUB NURSE JOINTLY INSPECTED THE BROKEN SUTURE AND CONFIRMED THAT THE NEEDLE TIP AND TAIL WERE INTACT, AFTER WHICH THE SURGEON WAS INFORMED. ANOTHER BARBED SUTURE WAS IMMEDIATELY REPLACED AND THE SURGERY CONTINUED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125954 ↗MalfunctionMay 8, 2026Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A GYNECOLOGICAL PROCEDURE, DURING UTERINE SUTURING, THE TIP OF THE NEEDLE FRACTURED. A SECOND SUTURE HAD A BROKEN THREAD. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25120526 ↗MalfunctionMay 8, 2026Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A GYNECOLOGICAL PROCEDURE, DURING UTERINE SUTURING, THE TIP OF THE NEEDLE FRACTURED. A SECOND SUTURE HAD A BROKEN THREAD. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25120430 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A UTERINE SUTURING PROCEDURE, THE NEEDLE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112561 ↗MalfunctionMay 5, 2026Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A GYNECOLOGICAL PROCEDURE, DURING UTERINE SUTURING, THE TIP OF THE NEEDLE FRACTURED. A SECOND SUTURE HAD A BROKEN THREAD. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089818 ↗MalfunctionApr 24, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, WHILE SUTURING THE MYOMA CAVITY, THE NEEDLE DETACHED FROM THE SUTURE. THE SUTURE WAS REMOVED AND A NEW ONE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983964 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT DURING MYOMECTOMY SUTURING, THE SUTURE BROKE IN THE MIDDLE. 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 24871769 ↗MalfunctionApr 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A MYOMECTOMY PROCEDURE, WHILE SUTURING, THE DEVICE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. 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 24768992 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING MULTIPLE HYSTERECTOMY PROCEDURES, THE SUTURE EXPERIENCED REPEATED NEEDLE DETACHMENT FROM THE SUTURE WHILE SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761329 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, A SUTURE WITH NEEDLE WAS USED TO CLOSE THE VAGINAL CUFF. DURING SUTURING, NEEDLE¿SUTURE SEPARATION OCCURRED AT THE CONNECTION SITE. THE SURGEON IMMEDIATELY SUSPENDED THE SUTURING WHICH DELAYED THE PROCEDURE, INSPECTED THE SURGICAL FIELD TO CONFIRM THAT NO FOREIGN MATERIAL REMAINED, AND REPLACED THE SUTURE TO RESOLVE THE ISSUE. VAGINAL CUFF CLOSURE WAS THEN RESTARTED AND COMPLETED SMOOTHLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758095 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING HYSTERECTOMY PROCEDURES, THE SUTURE EXPERIENCED NEEDLE DETACHMENT FROM THE SUTURE WHILE SUTURING, THE DE TACHED NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED USING A NEEDLE HOLDER. THE PROCEDURE WAS EXTENDED BY AT LEAST ONE HOUR DUE TO THE REPEATED ISSUE, AND THE PHYSICIAN ULTIMATELY USED AN ALTERNATIVE SUTURE TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737796 ↗MalfunctionMar 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING MULTIPLE HYSTERECTOMY PROCEDURES, THE SUTURE EXPERIENCED REPEATED NEEDLE DETACHMENT FROM THE SUTURE WHILE SUTURING, THE DETACHED NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED USING A NEEDLE HOLDER. THE PROCEDURE WAS EXTENDED BY AT LEAST ONE HOUR DUE TO THE REPEATED ISSUE, AND THE PHYSICIAN ULTIMATELY USED AN ALTERNATIVE SUTURE TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638068 ↗MalfunctionMar 18, 2026Break
ACCORDING TO THE REPORTER, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625150 ↗MalfunctionMar 17, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPEN KNEE REPLACEMENT, AT THE TIME OF JOINT CAPSULE SUTURING, UPON OPENING THE PACKAGE, TWO SUTURES WERE FOUND WITH DETACHED NEEDLE. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24620721 ↗MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY PRIOR TO PATIENT USE, THE SUTURE WAS BROKEN. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384432 ↗MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY PRIOR TO PATIENT USE, THE SUTURE WAS BROKEN. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384426 ↗MalfunctionFeb 16, 2026Break
IT WAS REPORTED THAT DURING A NEUROSURGICAL SPINAL SURGERY, THE NEEDLE BROKE, WITH TWO SUTURES FROM THE SAME BATCH ENCOUNTERING THE SAME PROBLEM. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24352858 ↗MalfunctionFeb 16, 2026Break
IT WAS REPORTED THAT DURING A NEUROSURGICAL SPINAL SURGERY, THE NEEDLE BROKE, WITH TWO SUTURES FROM THE SAME BATCH ENCOUNTERING THE SAME PROBLEM. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24352838 ↗MalfunctionFeb 16, 2026Break
ACCORDING TO THE REPORTER, DURING A NEUROSURGICAL SPINAL, THE NEEDLE BROKE WHILE PERFORMING A CONTINUOUS SUTURING TECHNIQUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344764 ↗MalfunctionFeb 13, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED AFTER THE FIRST STITCH WHILE SUTURING FOR SKIN CLOSURE. THE ISSUE OCCURRED IN FIVE SUTURES FROM THE SAME LOT. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333573 ↗MalfunctionFeb 13, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED AFTER THE FIRST STITCH WHILE SUTURING FOR SKIN CLOSURE. THE ISSUE OCCURRED IN FIVE SUTURES FROM THE SAME LOT. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333499 ↗MalfunctionFeb 13, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED AFTER THE FIRST STITCH WHILE SUTURING FOR SKIN CLOSURE. THE ISSUE OCCURRED IN FIVE SUTURES FROM THE SAME LOT. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENTINJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333474 ↗
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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 · each recall links to the FDA recall notice
- 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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