Coated VICRYL VCP587HRecalls & reported problems
Ethicon, LLC · Antibacterial Violet 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
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031054257), received between Dec 3, 2019 and Apr 29, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Failure to Degrade3
- Material Separation3
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient5
- Abscess3
- Impaired Healing3
- Pocket Erosion3
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Failure to Degrade
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR CLOSURE. POST-OP, AROUND THE 4TH WEEK AFTER THE PROCEDURE, HEALING OF THE PROSTHESES (KNEE OR HIP) EVOLVED BADLY. IT WAS OPINED THAT THE SUTURE MAY BE POORLY ABSORBED AND WAS EVACUATED TO THE SURFACE CREATING A MICRO ABSCESS. THE PATIENT HAD DELAYED HEALING AND STRESS/EVOLUTION OF CIATRIZATION. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Abscess; Impaired Healing; Pocket Erosion
MAUDE report 25034995 ↗MalfunctionApr 29, 2026Failure to Degrade
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR CLOSURE. POST-OP, AROUND THE 4TH WEEK AFTER THE PROCEDURE, HEALING OF THE PROSTHESES (KNEE OR HIP) EVOLVED BADLY. IT WAS OPINED THAT THE SUTURE MAY BE POORLY ABSORBED AND WAS EVACUATED TO THE SURFACE CREATING A MICRO ABSCESS. THE PATIENT HAD DELAYED HEALING AND STRESS/EVOLUTION OF CICATRIZATION. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Abscess; Impaired Healing; Pocket Erosion
MAUDE report 25034987 ↗MalfunctionApr 29, 2026Failure to Degrade
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR CLOSURE. POST-OP, AROUND THE 4TH WEEK AFTER THE PROCEDURE, HEALING OF THE PROSTHESES (KNEE OR HIP) EVOLVED BADLY. IT WAS OPINED THAT THE SUTURE MAY BE POORLY ABSORBED AND WAS EVACUATED TO THE SURFACE CREATING A MICRO ABSCESS. THE PATIENT HAD DELAYED HEALING AND STRESS/EVOLUTION OF CIATRIZATION. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Abscess; Impaired Healing; Pocket Erosion
MAUDE report 25034985 ↗MalfunctionSep 6, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 THREADS FROM THE SAME BOX BROKE AT THE FIRST KNOT DURING LIGATION OF THE OVARIES (AT THE END OF THE THREAD OPPOSITE THE NEEDLE) WITHOUT EXERTING EXCESSIVE TRACTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17689319 ↗MalfunctionSep 6, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 THREADS FROM THE SAME BOX BROKE AT THE FIRST KNOT DURING LIGATION OF THE OVARIES (AT THE END OF THE THREAD OPPOSITE THE NEEDLE) WITHOUT EXERTING EXCESSIVE TRACTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17689318 ↗MalfunctionSep 6, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 THREADS FROM THE SAME BOX BROKE AT THE FIRST KNOT DURING LIGATION OF THE OVARIES (AT THE END OF THE THREAD OPPOSITE THE NEEDLE) WITHOUT EXERTING EXCESSIVE TRACTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17689317 ↗MalfunctionAug 1, 2022Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER A SINGLE TISSUE PASSAGE AND WITHOUT EXERTING EXCESSIVE TENSION, THE NEEDLE PULLED FROM THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15142719 ↗MalfunctionAug 1, 2022Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER A SINGLE TISSUE PASSAGE AND WITHOUT EXERTING EXCESSIVE TENSION, THE NEEDLE PULLED FROM THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15142712 ↗MalfunctionAug 1, 2022Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER A SINGLE TISSUE PASSAGE AND WITHOUT EXERTING EXCESSIVE TENSION, THE NEEDLE PULLED FROM THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15142673 ↗MalfunctionMar 26, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY IN (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER A FEW TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE BROKE IN THE HEEL AREA. THE TIP OF THE NEEDLE FELL INTO THE ANIMAL ABDOMEN. THE VET RETRIEVED THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574576 ↗MalfunctionDec 4, 2019Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT AN ANIMAL PROCEDURE/CASTRATION IN 2019 AND THE SUTURE WAS USED. THE SUTURE SNAPPED IN HALF, NOT AT THE NEEDLE, WHILST PULLING THE SUTURE THROUGH THE SKIN WITH LITTLE FORCE APPLIED DURING UNINTERRUPTED CONTINUOUS SUTURE. A NEW SUTURE PACK WAS OPENED TO FINISH THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9407674 ↗MalfunctionDec 4, 2019Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT AN ANIMAL PROCEDURE/CASTRATION IN 2019 AND THE SUTURE WAS USED. THE SUTURE SNAPPED IN HALF, NOT AT THE NEEDLE, WHILST PULLING THE SUTURE THROUGH THE SKIN WITH LITTLE FORCE APPLIED DURING UNINTERRUPTED CONTINUOUS SUTURE. A NEW SUTURE PACK WAS OPENED TO FINISH THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9407667 ↗MalfunctionDec 4, 2019Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT AN ANIMAL PROCEDURE/CASTRATION IN 2019 AND THE SUTURE WAS USED. THE SUTURE SNAPPED IN HALF, NOT AT THE NEEDLE, WHILST PULLING THE SUTURE THROUGH THE SKIN WITH LITTLE FORCE APPLIED DURING UNINTERRUPTED CONTINUOUS SUTURE. A NEW SUTURE PACK WAS OPENED TO FINISH THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9407662 ↗MalfunctionDec 4, 2019Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT AN ANIMAL PROCEDURE/CASTRATION IN 2019 AND THE SUTURE WAS USED. THE SUTURE SNAPPED IN HALF, NOT AT THE NEEDLE, WHILST PULLING THE SUTURE THROUGH THE SKIN WITH LITTLE FORCE APPLIED DURING UNINTERRUPTED CONTINUOUS SUTURE. A NEW SUTURE PACK WAS OPENED TO FINISH THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9407646 ↗MalfunctionDec 3, 2019Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT AN ANIMAL PROCEDURE/CASTRATION IN 2019 AND THE SUTURE WAS USED. THE SUTURE SNAPPED IN HALF, NOT AT THE NEEDLE, WHILST PULLING THE SUTURE THROUGH THE SKIN WITH LITTLE FORCE APPLIED DURING UNINTERRUPTED CONTINUOUS SUTURE. A NEW SUTURE PACK WAS OPENED TO FINISH THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9407640 ↗
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
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- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 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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