V-Loc 180 VLOCL0014Recalls & 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 absorbable suture is a wound closure device that dissolves into the body over time. Reports mostly describe the suture loop snapping or coming apart, either before use or during skin suturing, so a new suture had to be used. There are 34 reports, with2 injuries and no deaths. One open recall, started in June 2026, concerns possible tears in the sterile barrier packaging that could contaminate the sutures and lead to infection or longer surgery.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521130371), received between Sep 18, 2017 and Aug 13, 2026 — classified as 2 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Break” (28 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
- Break28
- Detachment of Device or Device Component8
Patient problems
- No Known Impact Or Consequence To Patient16
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient6
- Foreign Body In Patient2
- Insufficient Information1
- No Code Available1
- Tissue Damage1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break
Patient problems: Insufficient Information
MAUDE report 50234201 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222470 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222433 ↗MalfunctionAug 6, 2026Break
According to the reporter, during dermal suturing, the loop 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 50150681 ↗MalfunctionSep 15, 2025Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE LOOP WAS BROKEN. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050993 ↗MalfunctionSep 12, 2025Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE PREPARING AND AFTER OPENING THE PACKAGE, THE LOOP WAS BROKEN. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23043345 ↗MalfunctionApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD CAME OUT OF THE NEEDLE DURING SUBCUTANEOUS SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21930187 ↗MalfunctionApr 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE LOOP AT THREAD BOTTOM WAS FOUND TO BE DETACHED DURING SUBCUTANEOUS DERMAL SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21879833 ↗MalfunctionOct 8, 2024Break; Break
ACCORDING TO THE REPORTER, DURING ARTIFICIAL HEAD REPLACEMENT DERMAL SUTURE, AT THE FEMORAL REGION, THE SUTURE BROKE AT THE FIRST AND SECOND STITCHES DURING DERMAL SUTURING. IT WAS NOTED THAT A NEW SUTURE WAS USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398309 ↗MalfunctionMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, WHILE SUTURING, THE SUTURE AND NEEDLE CAME OFF FROM THE LIGATURE PART. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11395821 ↗MalfunctionFeb 13, 2020Break; Break
ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC HIP PROCEDURE, WHEN PERFORMING DERMIS SUTURING, THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9707651 ↗MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A TOTAL HIP ANTHROPLASTY, UPON OPENING THE PACKET, THE NEEDLE WAS FOUND TO BE INCLUDED INSIDE IN A STATUS OF BEING BROKEN FROM THE SWAGE PART. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9126015 ↗InjuryJun 17, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS USED IN THE ARTIFICIAL JOINT PROCEDURE, THE NEEDLE BROKE. AFTER THE PROCEDURE THE TIP OF THE NEEDLE WAS NOTED TO BE MISSED AND REMAINED IN THE PATIENT'S BODY. THERE WAS TISSUE DAMAGE AND INCISION SITE WAS EXTENDED BY MORE THAN 3 CM.
Patient problems: Foreign Body In Patient; No Code Available; Tissue Damage
MAUDE report 8704654 ↗MalfunctionJun 11, 2019Break; Break
ACCORDING TO THE REPORTER, DURING ARTIFICIAL JOINT REPLACEMENT (HIP) PROCEDURE, WHEN THE DEVICE WAS USED IN ARTIFICIAL JOINT SURGERY, ONE SUTURE'S THREAD BROKE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8689574 ↗MalfunctionMay 16, 2019Break; Break
ACCORDING TO THE REPORTER, DURING TOTAL KNEE ARTHROPLASTY OF ORTHOPEDIC FIELD, THREAD BREAKAGE OCCURRED FREQUENTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8616158 ↗MalfunctionFeb 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE THE PRODUCT WAS IN USE FOR THE WOUND CLOSURE AFTER THE PACEMAKER IMPLANTATION, THE NEEDLE DISENGAGED DURING BACK BITE AT THE FINAL STITCH. IT WAS NOTED THE PRODUCT HAS BEEN DISCARDED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8300543 ↗InjuryOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, BOTH NEEDLE AND THREAD BROKE DURING A PROCEDURE, THEY REMAINED FOR A FEW MOMENTS IN THE ABDOMINAL WALL OF THE PATIENT, LOOKING AND TRYING TO RECOVER THE NEEDLE. HOWEVER, IT REMAINED STUCK IN THE PATIENT'S ABDOMINAL WALL.
Patient problems: Foreign Body In Patient
MAUDE report 8013788 ↗MalfunctionApr 18, 2018Break; Break
ACCORDING TO THE REPORTER, DURING DERMAL SUTURING OF THE PROCEDURE, THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7440936 ↗MalfunctionMar 6, 2018Break; Break
ACCORDING TO THE REPORTER; DURING THE SURGERY, THE NEEDLE WAS BROKEN NEAR THE SWAGE. NOTHING FELL INTO THE PATIENT. THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT. NO FURTHER PATIENT DETAILS WERE MADE AVAILABLE BY THE REPORTER/ACCOUNT. THE CASE WAS COMPLETE BY OPENING ANOTHER SUTURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7316593 ↗MalfunctionFeb 2, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOOP OF THE DEVICE WAS BROKEN WHEN IT WAS PULLED OUT OF THE PACKAGE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7235588 ↗MalfunctionJan 29, 2018Break; Break
ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, THE LOOP WAS BROKEN FORM THE FIRST. NOTHING FELL INTO PATIENT CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7226713 ↗MalfunctionDec 11, 2017Break; Break
ACCORDING TO THE REPORTER, DURING AN ARTIFICIAL HIP REPLACEMENT SURGERY, THE LOOP PART OF THE INSTRUMENT BROKE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7104434 ↗MalfunctionDec 8, 2017Break; Break
ACCORDING TO THE REPORTER, A DOCTOR HAD THE NEEDLE GO THROUGH THE LOOP AND TIED IT UP, THEN THE LOOP BROKE. NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7101663 ↗MalfunctionDec 5, 2017Break; Break
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LOOP WAS BROKEN FROM THE START. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE STATUS OF THE PATIENT: NO PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7083741 ↗MalfunctionNov 29, 2017Break; Break
ACCORDING TO THE REPORTER, THE LOOP BROKE WHEN THE FIRST STITCH GOT THROUGH AND THE THREAD WAS PULLED UP WITH A SLIGHT FORCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7067519 ↗
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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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