V-Loc VLOCN0604Recalls & 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 wound closure suture has 117 adverse event reports on file. Most describe the suture breaking during surgery, and some describe the needle coming loose from the suture during colon surgery. The reports include no deaths and 8 injuries, and no recalls name 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
- 112
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10884521134904), received between Aug 10, 2017 and Jul 9, 2026 — classified as 8 injuries, 104 malfunctions.
The most frequently reported specific device problem is “Break” (93 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
- Break93
- Detachment of Device or Device Component23
- Adverse Event Without Identified Device or Use Problem4
- Detachment Of Device Component1
- Material Frayed1
- Product Quality Problem1
- Unraveled Material1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Known Impact Or Consequence To Patient40
- No Consequences Or Impact To Patient8
- Insufficient Information5
- No Code Available2
- No Patient Involvement2
- Radiation Exposure, Unintended2
- Unspecified Tissue Injury2
Recent adverse event reports
The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770444 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL DURING COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE.
Patient problems: Insufficient Information
MAUDE report 24753124 ↗MalfunctionMar 19, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC GASTRIC BYPASS, WHILE ON COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS PROLONGED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637607 ↗MalfunctionMar 12, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL DURING COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE.
Patient problems: Insufficient Information
MAUDE report 24584951 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC GASTRIC BYPASS, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL DURING COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS PROLONGED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24478649 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE LOOP BROKE. 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 24361750 ↗MalfunctionFeb 9, 2026Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOOP WAS DAMAGED IMMEDIATELY AFTER USE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298703 ↗MalfunctionJan 30, 2026Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING INSIDE THE ABDOMEN, THE THREAD OF TWO SUTURES FROM DIFFERENT LOT NUMBERS BROKE. ONE SUTURE BROKE NEAR THE NEEDLE AND ONE SUTURE BROKE NEAR THE LOOP. THE ISSUE RESULTED TO EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220585 ↗MalfunctionJan 30, 2026Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING INSIDE THE ABDOMEN, THE THREAD OF TWO SUTURES FROM DIFFERENT LOT NUMBERS BROKE. ONE SUTURE BROKE NEAR THE NEEDLE AND ONE SUTURE BROKE NEAR THE LOOP. THE ISSUE RESULTED TO EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220543 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23518491 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23518487 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23518359 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23518060 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23517158 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23512649 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23512455 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23512389 ↗MalfunctionOct 29, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23413888 ↗MalfunctionOct 29, 2025Break; Break
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TEN DEVICES OF THE SAME PRODUCT AND LOT NUMBER. 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 23413858 ↗MalfunctionOct 22, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE SUTURE NEEDLE FRACTURED, BECOMING LODGED WITHIN THE PARIETAL PERITONEUM TISSUE. THIS EVENT LED TO PROLONGED SURGICAL AND ANESTHETIC TIME. THE SURGEON USED DIATHERMY TO OPEN THE AREA WHERE THE NEEDLE WAS LAST VISUALIZED INTACT IN ORDER TO RETRIEVE THE BROKEN FRAGMENT. ALL FRAGMENTS OF THE BROKEN NEEDLE WERE SUCCESSFULLY RETRIEVED. A REPLACEMENT SUTURE 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 23363157 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOT-ASSISTED LAPAROSCOPIC GASTRIC BYPASS, WHILE MAKING THE ANASTOMOSIS, THE THREAD NEEDLE BECAME LOOSE WHILE BEING INTRODUCED INTO THE PATIENT. IT WAS NOTED THAT TWO SUTURES WERE USED AND HAD THE SAME ISSUE. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SURGICAL TIME WAS EXTENDED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23059573 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOT-ASSISTED LAPAROSCOPIC GASTRIC BYPASS, WHILE MAKING THE ANASTOMOSIS, THE THREAD NEEDLE BECAME LOOSE WHILE BEING INTRODUCED INTO THE PATIENT. IT WAS NOTED THAT TWO SUTURES WERE USED AND HAD THE SAME ISSUE. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SURGICAL TIME WAS EXTENDED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23059476 ↗MalfunctionMay 26, 2025Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE END PART OF THE THREAD WAS LOOSE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084938 ↗MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC BYPASS, WHILE SUTURING, THE NEEDLE GOT DETACHED. THE SURGICAL TIME WAS EXTENDED NOT MORE THAN 30 MINUTES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753779 ↗MalfunctionMar 19, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A HERNIA PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. THIS ISSUE OCCURRED ON THREE DEVICES. TO RESOLE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646114 ↗
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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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