V-Loc 90 VLOCM0315Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc 90 (56)
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 is a Covidien V-Loc 90 absorbable wound closure suture. Most of the 65 reports describe the suture breaking during surgery, with needles tearing off and pieces coming away. Two reports involve injuries and no deaths. One open recall, started in June 2026, covers packaging that may have a hole or tear, which can 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
- 65
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521132467), received between Mar 29, 2018 and May 19, 2026 — classified as 2 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Break” (46 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-2918-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Break46
- Detachment of Device or Device Component25
- Adverse Event Without Identified Device or Use Problem2
- Component Missing1
- Detachment Of Device Component1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- Insufficient Information15
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- Radiation Exposure, Unintended1
- Unintended Radiation Exposure1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC VENTRAL HERNIA, SIX SUTURE NEEDLE TORE OFF.
Patient problems: Insufficient Information
MAUDE report 25222334 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC VENTRAL HERNIA, SIX SUTURE NEEDLE TORE OFF.
Patient problems: Insufficient Information
MAUDE report 25222315 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC VENTRAL HERNIA, SIX SUTURE NEEDLE TORE OFF.
Patient problems: Insufficient Information
MAUDE report 25222256 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC VENTRAL HERNIA, SIX SUTURE NEEDLE TORE OFF.
Patient problems: Insufficient Information
MAUDE report 25222189 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC VENTRAL HERNIA, SIX SUTURE NEEDLE TORE OFF.
Patient problems: Insufficient Information
MAUDE report 25222178 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC VENTRAL HERNIA, SIX SUTURE NEEDLE TORE OFF.
Patient problems: Insufficient Information
MAUDE report 25222145 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT INTRAOPERATIVELY, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE SAME THING OCCURRED WITH FOUR SUTURES FROM THE SAME BOX AND BATCH DURING THE SAME EVENT. 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 24842092 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT INTRAOPERATIVELY, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE SAME THING OCCURRED WITH FOUR SUTURES FROM THE SAME BOX AND BATCH DURING THE SAME EVENT. 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 24841739 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT INTRAOPERATIVELY, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE SAME THING OCCURRED WITH FOUR SUTURES FROM THE SAME BOX AND BATCH DURING THE SAME EVENT. 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 24838031 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT INTRAOPERATIVELY, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE SAME THING OCCURRED WITH FOUR SUTURES FROM THE SAME BOX AND BATCH DURING THE SAME EVENT. 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 24838022 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT INTRAOPERATIVELY, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE SAME THING OCCURRED WITH FOUR SUTURES FROM THE SAME BOX AND BATCH DURING THE SAME EVENT. 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 24830838 ↗MalfunctionMar 13, 2026Break
IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, TWO SUTURE THREADS BROKE WHILE PERFORMING A VAGINAL STUMP SUTURE. ANOTHER SUTURE THREAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594042 ↗MalfunctionFeb 11, 2026Break
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC HYSTERECTOMY, DURING VAGINAL STUMP SUTURING, THE THREAD BROKE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311713 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHILE PREPARING TO SUTURE THE OVARY, THE NEEDLE AND SUTURE WERE INTRODUCED INTO THE ABDOMINAL CAVITY THROUGH THE TROCAR. ONLY THE SUTURE WAS VISIBLE UNDER THE LAPAROSCOPIC VIEW, AS THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE HAD DETACHED. AFTER REMOVING THE TROCAR, THE NEEDLE WAS FOUND AND ANOTHER CLIP WAS USED TO CONTINUE THE SURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873625 ↗MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY, WHEN PULLED OUT FROM RETAINER, AND PREPARING FOR SUTURE BEFORE PATIENT USE, THE NEEDLE WAS DETACHED. A NEW SUTURES WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821210 ↗MalfunctionNov 26, 2025Break; Break
IT WAS REPORTED THAT DURING A CESAREAN SECTION PROCEDURE, THE SUTURE BROKE IN THE MIDDLE WHILE BEING PULLED THROUGH TISSUE WITHOUT ANY TENSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23661458 ↗MalfunctionNov 17, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC OVARIAN LESION RESECTION, DURING SUTURING, THE ABSORBABLE SUTURE BROKE. HEMOSTASIS MEASURES WERE IMMEDIATELY TAKEN, AND THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23566869 ↗MalfunctionOct 22, 2025Break; Break
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL HYSTERECTOMY, WHEN ON VAGINAL STUMP SUTURING, THE SUTURE THREAD BROKE. TO RESOLVE THE ISSUE, ANOTHER MANUFACTURER'S BARBED THREAD WAS USED FOR SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23363308 ↗MalfunctionOct 20, 2025Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SUTURE BROKEN DURING PREPARATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337675 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, WHILE SUTURING, TWO SUTURES FROM THE SAME PRODUCT AND BATCH BROKE IN THE MIDDLE. AFTER THE SECOND SUTURE BROKE, A DIFFERENT MANUFACTURER'S SUTURE WAS USED TO CLOSE THE WOUND. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23298056 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, WHILE SUTURING , TWO SUTURES FROM THE SAME PRODUCT AND BATCH BROKE IN THE MIDDLE. AFTER THE SECOND SUTURE BROKE, A DIFFERENT MANUFACTURER'S SUTURE WAS USED TO CLOSE THE WOUND. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23298018 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, BEFORE USING IT TO THE PATIENT, THE NEEDLE GOT LOOSE FROM SUTURE. A NEW CLIP APPLIER WAS THEN USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23057433 ↗MalfunctionAug 11, 2025Break; Break
ACCORDING TO THE REPORTER, THE TWO NEEDLES BROKE.
Patient problems: Insufficient Information
MAUDE report 22779179 ↗MalfunctionAug 8, 2025Break; Break
ACCORDING TO THE REPORTER, THE TWO NEEDLES BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22752461 ↗MalfunctionAug 8, 2025Break; Break
ACCORDING TO THE REPORTER, THE TWO NEEDLES BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749420 ↗
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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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