V-Loc VLOCN0306Recalls & reported problems
Covidien LP · PBT Non Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521134911), received between Aug 29, 2017 and Jul 9, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component5
- Break4
- Bent1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC REPAIR OF A VENTRAL HERNIA, WHILE THE PERITONEUM WAS BEING SUTURED, THE SUTURE THREAD SNAPPED CLOSE TO THE NEEDLE, BUT NOT AT THE NEEDLE-TO-SUTURE JOINT. THE NEEDLE THEN FELL INTO THE ABDOMEN, THOUGH IT WAS RETRIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763600 ↗MalfunctionJan 25, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA REPAIR, WHILE CLOSING THE DEFECT AND SECURING THE HERNIA MESH . A TOTAL OF THREE SUTURE THREADS SNAPPED AFTER TWO TO THREE PASSES THROUGH THE TISSUE WHILE USING NORMAL RUNNING STITCH. THE SURGEON REMOVED THE BROKEN PIECES OF THREAD AND USED A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13351533 ↗MalfunctionApr 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL EXTRA-PERITONEAL HERNIA REPAIR, FIVE THREADS DETACHED FROM NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11744451 ↗MalfunctionApr 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL EXTRA-PERITONEAL HERNIA REPAIR, FIVE THREADS DETACHED FROM NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11744442 ↗MalfunctionApr 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL EXTRA-PERITONEAL HERNIA REPAIR, FIVE THREADS DETACHED FROM NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11744431 ↗MalfunctionOct 22, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, AT THE END OF A ROBOTIC LAPAROSCOPIC HERNIA REPAIR, THE SUTURE THREAD BROKE. THE NEED WAS REMOVED FROM THE TROCAR TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10720687 ↗MalfunctionAug 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS ROUX-EN-Y, THE NEEDLE CAME OFF FROM THE SUTURE. IT WAS STATED THAT THE DEVICE FELL INTO THE PATIENT¿S CAVITY AND WAS RETRIEVED WITHOUT INCIDENT. A NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10400598 ↗MalfunctionJun 11, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA PROCEDURE, THE DEVICE THREAD BROKE. THEY OPENED ANOTHER PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7587339 ↗MalfunctionAug 29, 2017Bent; Difficult to Insert; Bent; Difficult to Insert
ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING USE IN A ROBOTIC LAPAROSCOPIC PROCEDURE, DURING CLOSURE, THE DEVICE¿S NEEDLE WAS BENT AND UNSUCCESSFULLY ATTEMPTED TO PASS IT THROUGH AN EIGHT MILLIMETER TROCAR DEVICE. THEY OPENED ANOTHER DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THE PATIENT OUTCOME WAS ASKED BUT UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6826943 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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