V-Loc VLOCN0326Recalls & reported problems
Covidien LP · PBT Non Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien V-Loc barbed suture is a non-absorbable synthetic suture used to close surgical wounds, including hernia repairs. Most of the 34 reports describe the suture loop or strand breaking while pulling tissue, sometimes more than once during the same procedure, so surgeons switched to another brand's suture to finish closing. One report involved a patient injury, and no deaths were reported. There have been no recalls naming 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
- 32
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 20884521127880), received between Oct 6, 2017 and Mar 4, 2026 — classified as 1 injury, 31 malfunctions.
The most frequently reported specific device problem is “Break” (25 reports).
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
Most reported problems
Device problems
- Break25
- Detachment of Device or Device Component6
- Defective Device1
- Material Separation1
- Patient-Device Incompatibility1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- No Consequences Or Impact To Patient3
- No Code Available2
- No Information1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE STRAND OF THE THREE SUTURES BROKE WHEN PULLING THE TISSUE. A NEW SUTURE FROM ANOTHER BRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510486 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE STRAND OF THE THREE SUTURES BROKE WHEN PULLING THE TISSUE. A NEW SUTURE FROM ANOTHER BRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510417 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE STRAND OF THE THREE SUTURES BROKE WHEN PULLING THE TISSUE. A NEW SUTURE FROM ANOTHER BRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504155 ↗MalfunctionFeb 17, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR, THE FIRST SUTURE BROKE DURING SUTURING, AND THE SECOND ONE ALSO BROKE. A THIRD SUTURE WAS PLACED SUCCESSFULLY WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365866 ↗MalfunctionFeb 17, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR, THE FIRST SUTURE BROKE DURING SUTURING, AND THE SECOND ONE ALSO BROKE. A THIRD SUTURE WAS PLACED SUCCESSFULLY WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365696 ↗MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT DURING A INTRAPERITONEAL ONLAY MESH (IPOM) PLUS, THE SUTURE BROKE IN THE MIDDLE. NO ADDITIONAL NEW SUTURE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845340 ↗MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A INGUINAL HERNIA, THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD AND ANOTHER SUTURE WAS USED BUT THE NEEDLE WAS BENT. 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 23459197 ↗MalfunctionSep 3, 2025Break; Break
IT WAS REPORTED THAT DURING ABDOMINOPLASTY CLOSURE; THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. THE SURGEON THEN USED A SECOND SUTURE OF THE SAME CODE AND LOT, WHICH ALSO BROKE. THE SURGEON RESOLVED THE ISSUE BY USING A SUTURE FROM ANOTHER BRAND. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22957894 ↗MalfunctionSep 3, 2025Break; Break
IT WAS REPORTED THAT DURING ABDOMINOPLASTY CLOSURE; THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. THE SURGEON THEN USED A SECOND SUTURE OF THE SAME CODE AND LOT, WHICH ALSO BROKE. THE SURGEON RESOLVED THE ISSUE BY USING A SUTURE FROM ANOTHER BRAND. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22957522 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING. 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 22347281 ↗MalfunctionJun 23, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. 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 22305935 ↗MalfunctionJan 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, DURING THE UTERINE MYOMECTOMY, THE SUTURE WAS NOT ABSORBED AFTER THE IMPLANTATION. EXTRACTION OF THE SUTURE WAS PERFORMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21168202 ↗MalfunctionMay 10, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SURGERY, THE THREAD OF THE TWO DEVICES BROKE. TO RESOLVE THE ISSUE, ANOTHER DEVICE OF THE SAME TYPE AND LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288268 ↗MalfunctionMay 10, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SURGERY, THE THREAD OF THE TWO DEVICES BROKE. TO RESOLVE THE ISSUE, ANOTHER DEVICE OF THE SAME TYPE AND LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288241 ↗MalfunctionDec 1, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A OPEN HERNIOPLASTY, WHEN THE APONEUROSIS WAS BEING SUTURED, WHEN THE SUTURE KNOT WAS BEING PULLED THE SMALLER PIECE BROKE. THE TISSUE WAS RE-SUTURED AND THE THREAD BROKE AGAIN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18249815 ↗MalfunctionOct 17, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA PROCEDURE, AT THE TIME OF CLOSING THE DEFECT USING AN UNIDIRECTIONAL SUTURING TECHNIQUE, THE NEEDLE BROKE. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17951213 ↗MalfunctionJun 30, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, WHEN SUTURING THE INCISIONAL HERNIA ABDOMINAL TISSUE INVOLVED, THE NEEDLE BROKE OFF INSIDE THE PATIENT BUT THEN RETRIEVED AND THE SUTURE REMAINED IN PLACE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17237302 ↗MalfunctionJan 6, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CLOSING, THE THREAD BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13177568 ↗MalfunctionNov 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OF THE TWO DEVICES POPPED OFF THE SUTURE WITH NO REAL RESISTANCE.
Patient problems: Insufficient Information
MAUDE report 12801402 ↗MalfunctionNov 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OF THE TWO DEVICES POPPED OFF THE SUTURE WITH NO REAL RESISTANCE.
Patient problems: Insufficient Information
MAUDE report 12801401 ↗MalfunctionOct 28, 2021Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON OPENING, THE THREAD WAS FOUND TO BE INCLUDED IN THE STATE THAT PARTIALLY BOUND AND THE THREAD BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12710242 ↗MalfunctionOct 19, 2021Material Separation; Defective Device
DURING A SURGICAL PROCEDURE A 0 VLOC NEEDLE POPPED OFF THE SUTURE WITH NO REAL RESISTANCE. 2 SUTURES FROM THE SAME LOT # HAD THE SAME PROBLEM.
Patient problems: Insufficient Information
MAUDE report 12656094 ↗MalfunctionJul 14, 2020Break; Break
ACCORDING TO THE REPORTER, DURING AN ABDOMINOPLASTY PROCEDURE, AT THE END OF THE PROCEDURE UPON CLOSING THE ABDOMINAL WALL, TWO THREAD OF SUTURES BROKE JUST AFTER OPENING THE PACKAGE WITH MINIMAL TENSION. A DIFFERENT SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10270996 ↗InjuryJun 3, 2020Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, THE PATIENT UNDERGO A TISSUE CLOSURE OF THE ABDOMINAL WALL ON A ROBOTIC VENTRAL HERNIA PROCEDURE, AND WHEN THE PATIENT WAS ABOUT TO WAKE UP AFTER THE PROCEDURE, IT WAS REPORTED THAT THE THREAD BROKE AND IN PHYSICALLY DISENGAGED INTO SEPARATE PIECES AT THE MIDDLE OF THE STITCH. TO RESOLVE THE ISSUE THE SURGEON HAD TO PUT BACK THE PATIENT INTO SLEEP, AND THEY HAD TO OPEN THE PATIENT TO RE-DO THE CLOSING OF THE DEFECT FROM THE TOP IN ORDER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES, AND PATIENT HAD LONGER TIME UNDER ANESTHESIA.
Patient problems: No Code Available
MAUDE report 10116245 ↗MalfunctionJul 12, 2019Break; Break
ACCORDING TO THE REPORTER, DURING HERNIA PROCEDURE, THE THREAD BROKE. THE SURGEON DID A KNOT TO CONTINUE USING THE SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8784529 ↗
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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
- 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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