Coated VICRYL VCPB978HRecalls & reported problems
Ethicon, LLC · Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (350)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031056794), received between Nov 29, 2022 and Aug 11, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Separation” (6 reports).
2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); 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
- Material Separation6
- Break1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211341 ↗MalfunctionAug 11, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211338 ↗MalfunctionFeb 20, 2026Material Separation
IT WAS REPORTED A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON AN UNKNOWN DATE IN -2026 AND SUTURE WAS USED. THE NEEDLE POPS OFF FROM THE SUTURE MATERIAL. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400355 ↗MalfunctionFeb 20, 2026Material Separation
IT WAS REPORTED A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON AN UNKNOWN DATE IN -2026 AND SUTURE WAS USED. THE NEEDLE POPS OFF FROM THE SUTURE MATERIAL. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400353 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION UNDER EPIDURAL ANESTHESIA+ADHESIOLYSIS+LIGATION OF THE ASCENDING BRANCH OF THE UTERINE ARTERY. PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE UTERUS WAS SUTURED WITH SUTURE, BUT THE SUTURE BROKE DURING SUTURING. TO AVOID INCREASED BLEEDING IN THE PATIENT, THE SAME TYPE AND MODEL OF SUTURE WAS IMMEDIATELY REPLACED AND RE SUTURED FOR REINFORCEMENT TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22154361 ↗MalfunctionNov 29, 2022Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN CYST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE OCCURRED. ALSO, THE NEEDLE GOT BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15876752 ↗MalfunctionNov 29, 2022Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN CYST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE OCCURRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15876750 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.
- Z-2145-2024 · May 10, 2024 · Open, ClassifiedVICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
- Z-1310-2009 · Feb 2, 2009 · TerminatedCoated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and
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
- 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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