Coated VICRYL VCP453H (UDI 10705031053366)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031053366), received between Mar 12, 2020 and Jul 12, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE VET IS SEEING A LOT OF REACTION IN THE ANIMALS WITH THE SUTURE. THE SUTURES BECOME INFECTED AFTER ABOUT 14 DAYS, THE VET SUSPECTS THAT IT IS DUE TO THE MILK PROTEIN THAT IS IN THE SUTURE. THERE WERE NO LASTING CONSEQUENCES FOR THE ANIMALS. THE INFECTED WOUNDS HAVE BEEN DISINFECTED AND THE ANIMALS HAVE BEEN GIVEN A COURSE OF ANTIBIOTICS TO TAKE HOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 19730299 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE VET IS SEEING A LOT OF REACTION IN THE ANIMALS WITH THE SUTURE. THE SUTURES BECOME INFECTED AFTER ABOUT 14 DAYS, THE VET SUSPECTS THAT IT IS DUE TO THE MILK PROTEIN THAT IS IN THE SUTURE. THERE WERE NO LASTING CONSEQUENCES FOR THE ANIMALS. THE INFECTED WOUNDS HAVE BEEN DISINFECTED AND THE ANIMALS HAVE BEEN GIVEN A COURSE OF ANTIBIOTICS TO TAKE HOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 19730280 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 3/6/2023 AND SUTURE WAS USED. THE SUTURE BROKE WHILE PUTTING PRESSURE/TENSION ON IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587435 ↗
• MalfunctionJun 27, 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 OF FROM THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837500 ↗
• MalfunctionMar 13, 2020Break; Break

  IT WAS REPORTED THAT THE CAT UNDERWENT AN OVARIECTOMY PROCEDURE IN (B)(6) 2019 AND SUTURE WAS USED. LESS THAN FIVE DAYS POST OP THE ANIMAL PRESENTED WITH AN INFLAMMATORY REACTION AND EVENTRATION. THE OVERLOCK OF THE MUSCULAR WALL WITH SUTURE WAS RUPTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831748 ↗
• MalfunctionMar 13, 2020Break; Break

  IT WAS REPORTED THAT THE CAT UNDERWENT AN OVARIECTOMY PROCEDURE IN (B)(6) 2019 AND SUTURE WAS USED. LESS THAN FIVE DAYS POST OP THE ANIMAL PRESENTED WITH AN INFLAMMATORY REACTION AND EVENTRATION. THE OVERLOCK OF THE MUSCULAR WALL WITH SUTURE WAS RUPTURED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9831663 ↗
• MalfunctionMar 12, 2020Break; Break

  IT WAS REPORTED THAT THE CAT UNDERWENT AN OVARIECTOMY PROCEDURE AND SUTURE WAS USED. LESS THAN 5 DAYS AFTER THE SURGERY, THE CAT PRESENTED WITH AN INFLAMMATORY REACTION AND A EVENTRATION. POST OP THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 9826439 ↗

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