V-Loc 180 VLOCL0345Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc 180 (61)
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.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521131040), received between Nov 8, 2017 and Sep 29, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (10 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-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Unraveled Material10
- Break5
- Detachment of Device or Device Component2
Patient problems
- Wound Dehiscence10
- No Clinical Signs, Symptoms or Conditions6
- Tissue Breakdown5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Unraveled Material
Patient problems: Wound Dehiscence
MAUDE report 50935124 ↗MalfunctionSep 29, 2026Unraveled Material
Patient problems: Wound Dehiscence
MAUDE report 50935115 ↗MalfunctionSep 29, 2026Unraveled Material
Patient problems: Wound Dehiscence
MAUDE report 50935103 ↗MalfunctionSep 29, 2026Unraveled Material
Patient problems: Wound Dehiscence
MAUDE report 50935083 ↗MalfunctionSep 29, 2026Unraveled Material
Patient problems: Wound Dehiscence
MAUDE report 50935033 ↗MalfunctionSep 28, 2026Unraveled Material
Patient problems: Tissue Breakdown; Wound Dehiscence
MAUDE report 50926070 ↗MalfunctionSep 28, 2026Unraveled Material
Patient problems: Tissue Breakdown; Wound Dehiscence
MAUDE report 50926056 ↗MalfunctionSep 28, 2026Unraveled Material
Patient problems: Tissue Breakdown; Wound Dehiscence
MAUDE report 50926041 ↗MalfunctionSep 28, 2026Unraveled Material
Patient problems: Tissue Breakdown; Wound Dehiscence
MAUDE report 50926012 ↗MalfunctionSep 28, 2026Unraveled Material
Patient problems: Tissue Breakdown; Wound Dehiscence
MAUDE report 50926000 ↗MalfunctionJan 2, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE CLOSING OF THE VAGINA TOP, THE TWO SUTURES BROKE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE SURGICAL TIME WAS EXTENDED BY 5 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952212 ↗MalfunctionJan 2, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE CLOSING OF THE VAGINA TOP, THE TWO SUTURES BROKE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE SURGICAL TIME WAS EXTENDED BY 5 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952197 ↗MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE ON THE TWO SUTURE THREAD CAME RIGHT OFF WHEN IT WAS PULLED THROUGH THE TISSUE. MORE SUTURES WERE OPENED FROM ANOTHER BOX WITH ANOTHER LOT NUMBER TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005702 ↗MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE ON THE TWO SUTURE THREAD CAME RIGHT OFF WHEN IT WAS PULLED THROUGH THE TISSUE. MORE SUTURES WERE OPENED FROM ANOTHER BOX WITH ANOTHER LOT NUMBER TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005525 ↗MalfunctionMar 7, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL STUMP, AFTER PULLING THE NEEDLE THROUGH THE LOOP (THE NEEDLE WAS STILL IN THE NEEDLE HOLDER), THE SUTURE BROKE APPROXIMATELY FIVE CENTIMETERS BEHIND THE NEEDLE. A SECOND SUTURE ALSO BROKE DURING THE SAME EVENT. TO RESOLVE THE ISSUE, A THIRD SUTURE FROM THE SAME BATCH WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18862676 ↗MalfunctionMar 7, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL STUMP, AFTER PULLING THE NEEDLE THROUGH THE LOOP (THE NEEDLE WAS STILL IN THE NEEDLE HOLDER), THE SUTURE BROKE APPROXIMATELY FIVE CENTIMETERS BEHIND THE NEEDLE. A SECOND SUTURE ALSO BROKE DURING THE SAME EVENT. TO RESOLVE THE ISSUE, A THIRD SUTURE FROM THE SAME BATCH WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18862667 ↗MalfunctionNov 8, 2017Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE TWO DEVICES' SUTURES BROKE. NO FURTHER DETAILS WERE PROVIDED. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7008856 ↗
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page