Syneture VLOCL2216Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of Syneture (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521762503), received between Jan 6, 2025 and Jan 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K091087); 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
- Break1
- Patient-Device Incompatibility1
Patient problems
- Insufficient Information1
- Tissue Breakdown1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2025Break; Break
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY, THE VLOC DEVICE BROKE WHILE BEING APPLIED TO THE CLOSING OF THE VAGINAL CUFF.
Patient problems: Insufficient Information
MAUDE report 21123525 ↗MalfunctionJan 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED VAGINAL CUFF CELLULITIS AND WAS TREATED FOR THIS CONDITION.
Patient problems: Tissue Breakdown; Unspecified Tissue Injury
MAUDE report 21085175 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.
- Z-2919-2026 · Jun 24, 2026 · Open, ClassifiedV-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0
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- 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
- 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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