V-Loc 90 VLOCM0345Recalls & 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
Quick summary
This is a Covidien V-Loc 90 absorbable surgical suture. Reports mostly describe the suture thread or needle breaking or detaching during suturing, occasionally leaving fragments in tissue. There are 40 reports naming this device, with no deaths and 1 injury. No recalls name this device. Reports fell to 1 in the last 12 months from 5 the year before.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884521132528), received between Mar 26, 2018 and Jan 26, 2026 — classified as 1 injury, 39 malfunctions.
The most frequently reported specific device problem is “Break” (29 reports).
1 other recall cover devices cleared under the same FDA submission (K100257); they may or may not involve this specific model.
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
- Break29
- Detachment of Device or Device Component13
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient8
- Insufficient Information6
- Unspecified Tissue Injury6
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING HYSTERECTOMY, WHILE SUTURING OR PREPARING SUTURE AFTER PATIENT INCISION NEEDLE DETACHMENT OCCURRED. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. THE PRODUCT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177465 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT DURING A SUTURING PROCEDURE, THE SUTURE BROKE.
Patient problems: Insufficient Information
MAUDE report 22176132 ↗MalfunctionApr 21, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC PROSTATE CASE, THE THREAD OF THE SUTURE BROKE IN THE MIDDLE. A SECOND SUTURE WAS OBTAINED, WHICH ALSO HAD A BROKEN THREAD. A THIRD SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21870648 ↗MalfunctionApr 21, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC PROSTATE CASE, THE THREAD OF THE SUTURE BROKE IN THE MIDDLE. A SECOND SUTURE WAS OBTAINED, WHICH ALSO HAD A BROKEN THREAD. A THIRD SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21870642 ↗MalfunctionApr 18, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, DURING PROSTATE REMOVAL, THE SUTURE BROKE WHILE SUTURING. THE SAME ISSUE OCCURRED WITH THE SECOND THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21867843 ↗MalfunctionApr 18, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, DURING PROSTATE REMOVAL, THE SUTURE BROKE WHILE SUTURING. THE SAME ISSUE OCCURRED WITH THE SECOND THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21867839 ↗MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A OPEN PROCEDURE, WHEN SUTURING THE SUBCUTANEOUS SKIN, THE NEEDLE DETACHED FROM THE SUTURE AND THE NEEDLE FELL INTO THE PATIENT'S CAVITY ALONG WITH THE NEEDLE DRIVER FOR ALL SIX SUTURES USED. THE NEEDLE WAS RETRIEVED WITH A GRASPER. THERE WAS MINIMAL DAMAGE ON THE PATIENT BUT UNNECESSARY ADDITIONAL BITES FROM THE INITIAL NEEDLE HAD TO BE TAKEN DUE TO USING NEW STRANDS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19227677 ↗MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A OPEN PROCEDURE, WHEN SUTURING THE SUBCUTANEOUS SKIN, THE NEEDLE DETACHED FROM THE SUTURE AND THE NEEDLE FELL INTO THE PATIENT'S CAVITY ALONG WITH THE NEEDLE DRIVER FOR ALL SIX SUTURES USED. THE NEEDLE WAS RETRIEVED WITH A GRASPER. THERE WAS MINIMAL DAMAGE ON THE PATIENT BUT UNNECESSARY ADDITIONAL BITES FROM THE INITIAL NEEDLE HAD TO BE TAKEN DUE TO USING NEW STRANDS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19227674 ↗MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A OPEN PROCEDURE, WHEN SUTURING THE SUBCUTANEOUS SKIN, THE NEEDLE DETACHED FROM THE SUTURE AND THE NEEDLE FELL INTO THE PATIENT'S CAVITY ALONG WITH THE NEEDLE DRIVER FOR ALL 6 SUTURES USED. THE NEEDLE WAS RETRIEVED WITH A GRASPER. THERE WAS MINIMAL DAMAGE ON THE PATIENT BUT UNNECESSARY ADDITIONAL BITES FROM THE INITIAL NEEDLE HAD TO BE TAKEN DUE TO USING NEW STRANDS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19227646 ↗MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A OPEN PROCEDURE, WHEN SUTURING THE SUBCUTANEOUS SKIN, THE NEEDLE DETACHED FROM THE SUTURE AND THE NEEDLE FELL INTO THE PATIENT'S CAVITY ALONG WITH THE NEEDLE DRIVER FOR ALL 6 SUTURES USED. THE NEEDLE WAS RETRIEVED WITH A GRASPER. THERE WAS MINIMAL DAMAGE ON THE PATIENT BUT UNNECESSARY ADDITIONAL BITES FROM THE INITIAL NEEDLE HAD TO BE TAKEN DUE TO USING NEW STRANDS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19227645 ↗MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A OPEN PROCEDURE, WHEN SUTURING THE SUBCUTANEOUS SKIN, THE NEEDLE DETACHED FROM THE SUTURE AND THE NEEDLE FELL INTO THE PATIENT'S CAVITY ALONG WITH THE NEEDLE DRIVER FOR ALL 6 SUTURES USED. THE NEEDLE WAS RETRIEVED WITH A GRASPER. THERE WAS MINIMAL DAMAGE ON THE PATIENT BUT UNNECESSARY ADDITIONAL BITES FROM THE INITIAL NEEDLE HAD TO BE TAKEN DUE TO USING NEW STRANDS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19227644 ↗MalfunctionMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN SUTURING THE SUBCUTANEOUS SKIN, THE NEEDLE DETACHED FROM THE SUTURE AND THE NEEDLE FELL INTO THE PATIENT'S CAVITY ALONG WITH THE NEEDLE DRIVER FOR ALL 6 SUTURES USED. THE NEEDLE WAS RETRIEVED WITH A GRASPER. THERE WAS MINIMAL DAMAGE ON THE PATIENT BUT UNNECESSARY ADDITIONAL BITES FROM THE INITIAL NEEDLE HAD TO BE TAKEN DUE TO USING NEW STRANDS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19222852 ↗MalfunctionDec 18, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, FOUR SUTURES SNAPPED, AND THE FIFTH SUTURE SUCCESSFULLY CLOSED THE VAGINAL CUFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347675 ↗MalfunctionDec 18, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, FOUR SUTURES SNAPPED, AND THE FIFTH SUTURE SUCCESSFULLY CLOSED THE VAGINAL CUFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347335 ↗MalfunctionDec 18, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, FOUR SUTURES SNAPPED, AND THE FIFTH SUTURE SUCCESSFULLY CLOSED THE VAGINAL CUFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347294 ↗MalfunctionDec 18, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, FOUR SUTURES SNAPPED, AND THE FIFTH SUTURE SUCCESSFULLY CLOSED THE VAGINAL CUFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347273 ↗MalfunctionMay 19, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC PROCEDURE, THE STRANDS BROKE. ANOTHER SUTURE FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16966081 ↗MalfunctionMay 19, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STRANDS BROKE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16965103 ↗MalfunctionMar 7, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC HYSTERECTOMY, WHEN THE SUTURE WAS APPLIED TO CLOSE THE VAGINA, THE THREAD BROKE FROM THE NEEDLE. ANOTHER SUTURE FROM THE SAME PACKAGE WAS USED, BUT SAME ISSUE OCCURRED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16499493 ↗MalfunctionFeb 20, 2023Break; Break
ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE FIRST SUTURE WAS OPENED WITH THREAD DETACHED FROM THE NEEDLE MIDWAY THROUGH SUTURING THE VAGINAL VAULT WHILE THE SECOND SUTURE SNAPPED MID LENGTH MIDWAY THROUGH SUTURING THE VAULT. THERE WAS NO EXCESSIVE FORCE PUT ON THE SUTURE MATERIAL TO CAUSE DAMAGE. ANOTHER SUTURE FROM THE SAME BOX 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 16404197 ↗MalfunctionFeb 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE FIRST SUTURE WAS OPENED WITH THREAD DETACHED FROM THE NEEDLE MIDWAY THROUGH SUTURING THE VAGINAL VAULT WHILE THE SECOND SUTURE SNAPPED MID LENGTH MIDWAY THROUGH SUTURING THE VAULT. THERE WAS NO EXCESSIVE FORCE PUT ON THE SUTURE MATERIAL TO CAUSE DAMAGE. ANOTHER SUTURE FROM THE SAME BOX 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 16401860 ↗MalfunctionAug 1, 2022Break; Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 15139687 ↗MalfunctionJun 29, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC HYSTERECTOMY PROCEDURE, THE THREAD OF THE DEVICE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A NEW BOX WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14859506 ↗MalfunctionJun 28, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, WHEN SUTURING THE VAGINAL TOP AT THE END OF THE PROCEDURE, THE THREAD OF THE DEVICE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A NEW BOX WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14843073 ↗MalfunctionFeb 4, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, ON INSERTION THROUGH A TROCAR FOR WOUND CLOSURE, THREAD BROKE. THE 2 SUTURES POPPED ROUGHLY 2 INCHES FROM THE SWAGE ON THE CONSECUTIVE THREADS. USED ANOTHER STRAND FROM ANOTHER BOX/LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13457854 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.
- Z-2918-2026 · Jun 24, 2026 · Open, ClassifiedV-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL
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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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