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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 3 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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, Classified
    VICRYL 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 · Terminated
    Coated 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

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Sources and updates

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