V-Loc 180 VLOCL0436Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device,GS-25,1x Green Strand · 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 used to close wounds surgically. Most of the 38 reports describe the suture strand breaking during surgery, and a few mention bleeding or slow healing; 4 reports involved injuries and no deaths were reported. One open recall, started in June 2026, says the sterile barrier packaging may be perforated or torn, which can contaminate the suture and lead to infection. Reports in the last 12 months fell from 10 to 5.
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
- 39
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10884521131088), received between Sep 19, 2018 and Sep 21, 2026 — classified as 4 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Break” (29 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
- Break29
- Detachment of Device or Device Component9
- Adverse Event Without Identified Device or Use Problem5
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Hemorrhage/Blood Loss/Bleeding4
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Detachment of Device or Device Component
According to the reporter, during a procedure, the needle was not attached to the thread and it fell off while removing it from the retainer. It was not used on the patient. A new suture was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839799 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50420639 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50420636 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50420620 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211185 ↗MalfunctionMay 29, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, DURING THE SURGICAL SUTURING PROCESS, THE SAME SUTURE BROKE THREE TIMES. AFTER KNOTTING, THE SUTURING WAS CONTINUED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333676 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT SURGERY, TWO SUTURES BROKE WHILE TIGHTENING THE STRAND IN TISSUE AND DURING SUTURING. THE ISSUE OCCURRED WHILE CLOSING THE JOINT CAPSULE, INVOLVING TWO DEFECTIVE SUTURES IN THE SAME EVENT WITH THE SAME PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583848 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT SURGERY, TWO SUTURES BROKE WHILE TIGHTENING THE STRAND IN TISSUE AND DURING SUTURING. THE ISSUE OCCURRED WHILE CLOSING THE JOINT CAPSULE, INVOLVING TWO DEFECTIVE SUTURES IN THE SAME EVENT WITH THE SAME PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583836 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT DURING A LEFT TOTAL KNEE PROCEDURE, THREE CONSECUTIVE STRANDS OF SUTURE BROKE DURING CAPSULE CLOSURE. THE PHYSICIAN SWITCHED TO OTHER MANUFACTURER DEVICE TO COMPLETE THE CLOSURE AFTER THE SUTURE BREAKAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583763 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT DURING A LEFT TOTAL KNEE PROCEDURE, THREE CONSECUTIVE STRANDS OF SUTURE BROKE DURING CAPSULE CLOSURE. THE PHYSICIAN SWITCHED TO OTHER MANUFACTURER DEVICE TO COMPLETE THE CLOSURE AFTER THE SUTURE BREAKAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583742 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT DURING A LEFT TOTAL KNEE PROCEDURE, THREE CONSECUTIVE STRANDS OF SUTURE BROKE DURING CAPSULE CLOSURE. THE PHYSICIAN SWITCHED TO OTHER MANUFACTURER DEVICE TO COMPLETE THE CLOSURE AFTER THE SUTURE BREAKAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583737 ↗MalfunctionJan 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, THE NEEDLE AND THREAD DETACHED WHILE 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 21284324 ↗MalfunctionJan 31, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, WHILE SUTURING THE TISSUE, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282585 ↗MalfunctionJan 27, 2025Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL PROCEDURE, WHILE PERFORMING THE CONTINUOUS SUTURING TECHNIQUE, THE THREAD 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 21242271 ↗MalfunctionNov 12, 2024Break; Break
ACCORDING TO THE REPORTER, DURING CAPSULE CLOSURE FOR TOTAL KNEE ARTHROPLASTY, THE STRAND WAS BREAKING. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20665886 ↗MalfunctionNov 11, 2024Break; Break
ACCORDING TO THE REPORTER, IN A TOTAL KNEE ARTHROPLASTY, THE SUTURE STRAND BROKE DURING CAPSULE CLOSURE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20660574 ↗MalfunctionApr 11, 2024Break; Use of Device Problem; Break; Use of Device Problem
ACCORDING TO THE REPORTER, IN AN OPEN RIGHT TOTAL HIP REPLACEMENT, WHEN CLOSING THE WOUND AND SUTURING THE SUBCUTANEOUS TISSUE AFTER AN ORTHOPEDIC ILIAC JOINT REPLACEMENT, WHEN THE WOUND WAS CLOSED AND THE SUBCUTANEOUS TISSUE WAS SUTURED, IT WAS FOUND THAT THE BARB SUTURE'S BARB COULD NOT HOOK THE TISSUE. THE SURGEON USED ORDINARY SUTURES TO COMPLETE THE SUTURE. SIX MINUTES INTO THE PROCEDURE, WHILE USING CONTINUOUS SUTURING TECHNIQUE, THE SUTURE THREAD ALSO BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19091140 ↗MalfunctionMay 24, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UTERINE MYOMECTOMY, THE SUTURE THREAD HAD BROKE WHILE SUTURING THE UTERUS TO CLOSE THE WOUND. AS A RESULT, IT TOOK TWO CONSECUTIVE TIMES TO REMOVED THE BROKEN THREAD FROM THE PATIENT'S BODY, WHICH TOOK A LOT OF TIME. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY AN HOUR DUE TO DEVICE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16995350 ↗MalfunctionApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL SURGERY, SUTURING OF THE TISSUE. THE NEEDLE AND THE THREAD DETACHED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16839330 ↗MalfunctionApr 3, 2023Break; Break
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN CLOSURE OF THE UTERUS WAS ALMOST COMPLETE, STRANDS BROKE WITH ABOUT THREE INCHES LEFT TO THEM. ANOTHER SUTURE WAS PULLED TO FINISH CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16667299 ↗MalfunctionApr 3, 2023Break; Break
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN CLOSURE OF THE UTERUS WAS ALMOST COMPLETE, STRAND BROKE WITH ABOUT THREE INCHES LEFT. ANOTHER SUTURE WAS PULLED TO FINISH CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16666997 ↗MalfunctionApr 3, 2023Break; Break
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN CLOSURE OF THE UTERUS WAS ALMOST COMPLETE, STRAND BROKE WITH ABOUT THREE INCHES LEFT. ANOTHER SUTURE WAS PULLED TO FINISH CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16666251 ↗MalfunctionApr 3, 2023Break; Break
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN CLOSURE OF THE UTERUS WAS ALMOST COMPLETE, STRAND BROKE WITH ABOUT THREE INCHES LEFT. ANOTHER SUTURE WAS PULLED TO FINISH CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16666148 ↗MalfunctionApr 3, 2023Break; Break
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN CLOSURE OF THE UTERUS WAS ALMOST COMPLETE, STRAND BROKE WITH ABOUT THREE INCHES LEFT. ANOTHER SUTURE WAS PULLED TO FINISH CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16666029 ↗MalfunctionApr 3, 2023Break; Break
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN CLOSURE OF THE UTERUS WAS ALMOST COMPLETE, STRAND BROKE WITH ABOUT THREE INCHES LEFT. ANOTHER SUTURE WAS PULLED TO FINISH CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16665969 ↗
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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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