V-Loc 90 VLOCM0644Recalls & 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 Covidien V-Loc 90 absorbable wound closure suture is used to close surgical incisions. Most of the 49 reports describe the suture breaking during surgery or the needle coming loose or detaching from the suture thread, sometimes leaving the needle inside the abdominal cavity where it has to be located and pulled out, adding time to the operation. There are 3 injuries and no deaths. 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
- 47
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521132962), received between Mar 15, 2018 and Aug 12, 2026 — classified as 3 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Break” (27 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
- Break27
- Detachment of Device or Device Component21
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information6
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient3
- No Code Available2
- Foreign Body In Patient1
- No Patient Involvement1
- Tissue Breakdown1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217730 ↗MalfunctionMar 20, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING AFTER THE PATIENT INCISION, RESULTING IN THE NEEDLE FALLING INTO THE ABDOMINAL CAVITY. THE SURGICAL TEAM HAD TO SEARCH FOR AND SUCCESSFULLY RETRIEVED THE NEEDLE IN THE ABDOMINAL CAVITY, WHICH EXTENDED THE SURGICAL TIME BY TWENTY MINUTES. TWO SUTURES HAD THE SAME ISSUE. 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 24647962 ↗MalfunctionMar 20, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING AFTER THE PATIENT INCISION, RESULTING IN THE NEEDLE FALLING INTO THE ABDOMINAL CAVITY. THE SURGICAL TEAM HAD TO SEARCH FOR AND SUCCESSFULLY RETRIEVED THE NEEDLE IN THE ABDOMINAL CAVITY, WHICH EXTENDED THE SURGICAL TIME BY TWENTY MINUTES. TWO SUTURES HAD THE SAME ISSUE. 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 24647895 ↗MalfunctionAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA SURGERY, SPECIFICALLY DURING PERITONEAL CLOSURE USING A CONTINUOUS SUTURE TECHNIQUE, THE SUTURE DETACHED FROM THE NEEDLE TAIL. THE DEVICE HAD BEEN OPENED ONE MINUTE PRIOR TO USE AND WAS NOT TREATED OR HYDRATED BEFORE APPLICATION. THE ISSUE OCCURRED FIVE MINUTES INTO THE PROCEDURE. TO RESOLVE THE SITUATION, BARBED SUTURES FROM ANOTHER MANUFACTURER WERE USED TO COMPLETE THE SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22840952 ↗MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THREE SUTURES FROM THE BATCH POPPED DURING A CLOSURE. A NEW SUTURE WAS USED, AND THE CLOSURE WAS COMPLETED WITHOUT FURTHER ISSUES.
Patient problems: Insufficient Information
MAUDE report 22629224 ↗MalfunctionJul 9, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ABSORBABLE WOUND SUTURE WAS FOUND TO BE BROKEN. STOPPED USING IMMEDIATELY, SEAL AND HANDED OVER TO THE MEDICAL EQUIPMENT DEPARTMENT.
Patient problems: Insufficient Information
MAUDE report 22464729 ↗MalfunctionJun 17, 2025Break; Break
ACCORDING TO THE REPORTER DURING A ROBOTIC LAPAROSCOPIC SURGERY, THE NEEDLE WAS BROKEN AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS RETRIEVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22235877 ↗MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PAIN IMPLANT PROCEDURE, A NEEDLE DETACHMENT FROM THE SUTURE OCCURRED WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION, SPECIFICALLY DURING THE CLOSING STEP. 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 21684931 ↗MalfunctionMar 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN PAIN IMPLANT PROCEDURE, A NEEDLE DETACHMENT FROM THE SUTURE OCCURRED WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE DEVICE WAS BEING APPLIED DURING THE CLOSING STEP OF THE PROCEDURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY, AND 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 21578026 ↗MalfunctionDec 30, 2024Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE SUTURE THREAD BROKE 10 MINUTES INTO THE OPERATION WHILE SUTURING THE PERITONEUM. THE SURGICAL TEAM RE-TOOK THE SUTURE TO CONTINUE THE PROCEDURE AND SUBSEQUENTLY USED AN ADDITIONAL NEW SUTURE FROM A DIFFERENT PRODUCT ID AND LOT NUMBER WITHOUT ISSUE. THE BROKEN THREAD WAS THE ONLY DEFECTIVE DEVICE INVOLVED, AND NO FURTHER SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITHOUT EXTENDING THE SURGICAL TIME OR CAUSING ANY INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21035630 ↗MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE AND THREAD SEPARATED FOR FIVE SUTURES. THE SURGERY WAS COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208199 ↗MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE AND THREAD SEPARATED FOR FIVE SUTURES. THE SURGERY WAS COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208125 ↗MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE AND THREAD SEPARATED FOR FIVE SUTURES. THE SURGERY WAS COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208095 ↗MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE AND THREAD SEPARATED FOR FIVE SUTURES. THE SURGERY WAS COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207962 ↗MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE AND THREAD SEPARATED FOR FIVE SUTURES. THE SURGERY WAS COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207427 ↗MalfunctionMay 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD. THE PATIENT WAS UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387804 ↗MalfunctionMar 11, 2024Break; Break
ACCORDING TO THE REPORTER, IN A ROBOT-ASSISTED COELIO HYSTERECTOMY, WHEN CLOSING THE VAGINAL SLICE, TO JOIN WITH THE HELP OF AN OVERLOCK USING THE SUTURE, THE CENTER OF THE SUTURE WIRE BROKE. ANOTHER SUTURE WAS TAKEN. HOWEVER, THE SECOND SUTURE ALSO SHOWED AN AREA OF FRAGILITY. THE SECOND THREAD WAS LOOSE AT THE NEEDLE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 18876656 ↗MalfunctionMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, IN A ROBOT-ASSISTED COELIO HYSTERECTOMY, WHEN CLOSING THE VAGINAL SLICE, TO JOIN WITH THE HELP OF AN OVERLOCK USING THE SUTURE, THE CENTER OF THE SUTURE WIRE BROKE. ANOTHER SUTURE WAS TAKEN. HOWEVER, THE SECOND SUTURE ALSO SHOWED AN AREA OF FRAGILITY. THE SECOND THREAD WAS LOOSE AT THE NEEDLE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 18876590 ↗MalfunctionFeb 29, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC COLORECTAL PROCEDURE, VIA THE RUNNING STITCH TECHNIQUE, THREE SUTURES BROKE FROM THE SAME BOX. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18813566 ↗MalfunctionFeb 29, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC COLORECTAL PROCEDURE, VIA THE RUNNING STITCH TECHNIQUE, THREE SUTURES BROKE FROM THE SAME BOX. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18813542 ↗MalfunctionFeb 29, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC COLORECTAL PROCEDURE, VIA THE RUNNING STITCH TECHNIQUE, THREE SUTURES BROKE FROM THE SAME BOX. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18811125 ↗MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN CLOSING THE HERNIA SAC, THE NEEDLE POPPED OFF WHILE IN USE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18809592 ↗MalfunctionSep 26, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGY PROCEDURE, DURING A PERITONIZATION, THE THREAD BROKE WHEN THE SUTURE WAS BEING TIGHTENED DIRECTLY IN THE WOUND. THE BROKEN SUTURE WAS REMOVED, AND THE SURGEON USED A NEW SUTURE TO REPEAT THE STITCHES. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821415 ↗MalfunctionSep 26, 2023Break; Break
ACCORDING TO THE REPORTER, TWENTY MINUTES INTO A LAPAROSCOPIC OBGYN PROCEDURE, DURING PERITONIZATION, THE THREAD OF THE DEVICE BROKE WHEN TIGHTENED DIRECTLY IN THE WOUND. THE BROKEN SUTURE WAS REMOVED. WHEN ANOTHER SUTURE WAS USED, THE STITCHES WERE REPEATED, WHICH CAUSED TISSUE DAMAGE.
Patient problems: Tissue Breakdown
MAUDE report 17817439 ↗MalfunctionJul 6, 2023Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD WAS BROKEN FOR THE 12 UNITS. THE PRODUCT WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17270245 ↗
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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- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
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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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