V-Loc 180 VLOCL0604Recalls & 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 absorbable suture has 325 reports, with 29 injuries and no deaths. Most describe the thread breaking or parts detaching during surgery. It has 1 recall, still open since June 2026, over a tear in the sterile packaging that could let germs reach 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
- 328
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 328 adverse event reports that list this exact device (DI 10884521131132), received between Jul 26, 2017 and Sep 22, 2026 — classified as 29 injuries, 299 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (174 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
- Detachment of Device or Device Component174
- Break140
- Component Missing12
- Unraveled Material10
- Adverse Event Without Identified Device or Use Problem5
- Detachment Of Device Component3
- Use of Device Problem3
- Difficult to Open or Close2
Patient problems
- No Clinical Signs, Symptoms or Conditions210
- Insufficient Information36
- No Known Impact Or Consequence To Patient35
- No Consequences Or Impact To Patient22
- No Patient Involvement11
- No Code Available8
- Unintended Radiation Exposure8
- Foreign Body In Patient7
Recent adverse event reports
The 25 most recent of 328 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859081 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836057 ↗MalfunctionSep 3, 2026Break
According to the reporter, during a laparoscopic inguinal hernia repair, prior to handling after opening the package, the loop was damaged. A new suture was used without any problems. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589093 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50489084 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453258 ↗MalfunctionAug 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439257 ↗MalfunctionAug 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50432883 ↗MalfunctionAug 21, 2026Detachment of Device or Device Component
According to the reporter, during a laparoscopic small bowel polypectomy, at the beginning of suturing, the needle and 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 50373168 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068845 ↗MalfunctionJul 8, 2026Break
ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC MEDIASTINAL TUMOR RESECTION, WHILE SUTURING, THE TERMINAL FIXED LOOP OF THE SUTURE DETACHED. TO RESOLVE THE ISSUE, THE SURGEON SWITCHED TO A TRADITIONAL MANUAL KNOT-TYING SUTURING TECHNIQUE TO COMPLETE WOUND CLOSURE. SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 5 MINUTES AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 25743864 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, WHILE SUTURING THE OVARIAN TISSUE, THE SUTURE BROKE HALFWAY. IT WAS REPLACED WITH ANOTHER SUTURE OF THE SAME MODEL, BUT IT BROKE AGAIN AT THE SECOND STITCH. THE SUTURE WAS THEN REPLACED AGAIN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669845 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, WHILE SUTURING THE OVARIAN TISSUE, THE SUTURE BROKE HALFWAY. IT WAS REPLACED WITH ANOTHER SUTURE OF THE SAME MODEL, BUT IT BROKE AGAIN AT THE SECOND STITCH. THE SUTURE WAS THEN REPLACED AGAIN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669834 ↗MalfunctionJun 23, 2026Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER IT WAS OPENED DURING PREPARATION, THE LOOP WAS DAMAGED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596608 ↗InjuryJun 9, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED FROM THE STRAND AND FELL INTO THE PATIENT'S CAVITY AND WAS NOT RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 25439675 ↗MalfunctionMay 22, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PHYSICIAN WAS USING AN ABSORBABLE SUTURE, THE NEEDLE AND THREAD SUDDENLY WERE DETACHED. USE WAS IMMEDIATELY STOPPED, AND A NEW ABSORBABLE SUTURE OF THE SAME ORIGIN, MODEL, AND LOT NUMBER WAS REPLACED. NO HARM WAS CAUSED BY THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256864 ↗MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT DURING A HERNIA SURGERY, WHEN CLOSING THE PERITONEUM, THE PRE-FORMED LOOP DETACHED AFTER THE SECOND OR THIRD PASS. IT WAS REPORTED THAT THERE WAS NO EXCESSIVE TRACTION ON THE SUTURE AND THE MANEUVER WAS ROUTINE FOR THE SURGEON. THE SUTURING WAS COMPLETED USING ANOTHER DEVICE OF THE SAME REFERENCE WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237734 ↗MalfunctionMay 8, 2026Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, PRIOR TO PATIENT USE, WHEN THE PHYSICIAN OPENED THE PACKAGE TO INSPECT THE ABSORBABLE BARBED SUTURE, THE SUTURE WAS FOUND TO BE BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128616 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING TISSUE SUTURING IN A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE OF THE NINE BARBED SUTURES BROKE. TO COMPLETE THE CASE, A NEW DEVICE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS OPENED AND 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 25011795 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING TISSUE SUTURING IN A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE OF THE NINE BARBED SUTURES BROKE. TO COMPLETE THE CASE, A NEW DEVICE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS OPENED AND 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 25011778 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING TISSUE SUTURING IN A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE OF THE NINE BARBED SUTURES BROKE. TO COMPLETE THE CASE, A NEW DEVICE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS OPENED AND 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 25011774 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING TISSUE SUTURING IN A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE OF THE NINE BARBED SUTURES BROKE. TO COMPLETE THE CASE, A NEW DEVICE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS OPENED AND 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 25011731 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING TISSUE SUTURING IN A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE OF THE NINE BARBED SUTURES BROKE. TO COMPLETE THE CASE, A NEW DEVICE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS OPENED AND 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 25011722 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING TISSUE SUTURING IN A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE OF THE NINE BARBED SUTURES BROKE. TO COMPLETE THE CASE, A NEW DEVICE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS OPENED AND 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 25011705 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING TISSUE SUTURING IN A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE OF THE NINE BARBED SUTURES BROKE. TO COMPLETE THE CASE, A NEW DEVICE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS OPENED AND 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 25011645 ↗MalfunctionApr 8, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE WAS DISCONNECTED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818525 ↗
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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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