Coated VICRYL VCP504GRecalls & reported problems
Ethicon, LLC · Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (350)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031053922), received between Sep 4, 2026 and Sep 4, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- Impaired Healing4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2026Break
It was reported that a patient underwent an Entropion or Ectropion repair and suture was used. The suture was dissolving before the patient's eye was healed. The patient had to be brought back for revision surgery on (b)(6) 2026 and a different type of suture was used. No further issues were noted. Patients healed appropriately. Device is available for return. Additional information was requested.
Patient problems: Impaired Healing
MAUDE report 50615893 ↗InjurySep 4, 2026Break
It was reported that a patient underwent an Entropion or Ectropion repair and suture was used. The suture was dissolving before the patient's eye was healed. The patient had to be brought back for revision surgery on (b)(6) 2026 and a different type of suture was used. No further issues were noted. Patients healed appropriately. Device is available for return. Additional information was requested.
Patient problems: Impaired Healing
MAUDE report 50615808 ↗InjurySep 4, 2026Break
It was reported that a patient underwent an Entropion or Ectropion repair and suture was used. The suture was dissolving before the patient's eye was healed. The patient had to be brought back for revision surgery on (b)(6) 2026 and a different type of suture was used. No further issues were noted. Patients healed appropriately. Device is available for return. Additional information was requested.
Patient problems: Impaired Healing
MAUDE report 50615807 ↗InjurySep 4, 2026Break
It was reported that a patient underwent an Entropion or Ectropion repair and suture was used. The suture was dissolving before the patient's eye was healed. The patient had to be brought back for revision surgery on (b)(6) 2026 and a different type of suture was used. No further issues were noted. Patients healed appropriately. Device is available for return. Additional information was requested.
Patient problems: Impaired Healing
MAUDE report 50615798 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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