Coated VICRYL VCP398H (UDI 10705031052987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031052987), received between Mar 7, 2018 and Jan 14, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SUTURING THE ABDOMINAL WALL, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF THE THREAD. THIS PROBLEM OCCURRED ON TWO VICRYL PLUS SUTURES, ON TWO OOPHORECTOMIES OF DIFFERENT CATS. THE SURGERIES WERE COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE ON THE ANIMALS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075254 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SUTURING THE ABDOMINAL WALL, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF THE THREAD. THIS PROBLEM OCCURRED ON 2 VICRYL PLUS VCP398H, ON TWO OOPHORECTOMIES OF DIFFERENT CATS. THE SURGERIES WERE COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE ON THE ANIMALS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075237 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY (BILATERAL) PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. WHEN THE VETERINARIAN MADE THE LIGATIONS OF THE 2 OVARIES, WITHOUT EXERTING EXCESSIVE TENSION, THE NEEDLE DETACHED FROM THE THREAD. THE SURGERY COULD BE PERFORMED USING ANOTHER THREAD FROM THE SAME BOX WITHOUT AFFECTING THE CAT TO DATE.NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850095 ↗
• MalfunctionFeb 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF DURING TISSUE PASSAGE. THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351821 ↗
• MalfunctionDec 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE OVERLOCK OF THE ABDOMINAL WALL, AFTER A FEW TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF FROM THE THREAD. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WITHOUT AFFECTING THE ANIMAL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018947 ↗
• MalfunctionDec 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE IN NOVEMBER 2022 AND SUTURE WAS USED. DURING THE OVERLOCK OF THE ABDOMINAL WALL, AFTER A FEW TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF FROM THE THREAD. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WITHOUT AFFECTING THE ANIMAL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017044 ↗
• MalfunctionDec 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE OVERLOCK OF THE ABDOMINAL WALL, AFTER A FEW TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF FROM THE THREAD. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WITHOUT AFFECTING THE ANIMAL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017039 ↗
• MalfunctionDec 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE OVERLOCK OF THE ABDOMINAL WALL, AFTER A FEW TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF FROM THE THREAD. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WITHOUT AFFECTING THE ANIMAL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016865 ↗
• MalfunctionJul 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE CANNOT BE USED BECAUSE AT THE FIRST STEP ON THE TISSUE THE NEEDLE DETACHED FROM THE WIRE THE STITCH HAS BEEN PULLED OUT AND A NEW ONE ENTERED. THIS CAUSE A SLIGHT DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108871 ↗
• MalfunctionJul 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE CANNOT BE USED BECAUSE AT THE FIRST STEP ON THE TISSUE THE NEEDLE DETACHED FROM THE WIRE THE STITCH HAS BEEN PULLED OUT AND A NEW ONE ENTERED. THIS CAUSE A SLIGHT DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108774 ↗
• MalfunctionJul 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE CANNOT BE USED BECAUSE AT THE FIRST STEP ON THE TISSUE THE NEEDLE DETACHED FROM THE WIRE THE STITCH HAS BEEN PULLED OUT AND A NEW ONE ENTERED. THIS CAUSE A SLIGHT DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108742 ↗
• MalfunctionJul 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE CANNOT BE USED BECAUSE AT THE FIRST STEP ON THE TISSUE THE NEEDLE DETACHED FROM THE WIRE THE STITCH HAS BEEN PULLED OUT AND A NEW ONE ENTERED. THIS CAUSE A SLIGHT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108528 ↗
• MalfunctionJun 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE THREAD. NO INFORMATION REGARDING THE NUMBER OF IMPACTED UNITS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653322 ↗
• MalfunctionJun 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE THREAD. NO INFORMATION REGARDING THE NUMBER OF IMPACTED UNITS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653317 ↗
• MalfunctionMay 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14475543 ↗
• MalfunctionMay 3, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS MENTIONED THAT THE NEEDLE CAME LOOSE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269600 ↗
• MalfunctionMar 7, 2018Break; Break

  IT WAS REPORTED BY THE VET THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THREE OR FOUR DAYS POST OP THE VET NOTED A RUPTURE OF THE ABDOMINAL WALL SUTURE. THE KNOTS WERE INTACT. THE ANIMAL HAD A NEW SURGERY FOR EVENTRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321011 ↗
• MalfunctionMar 7, 2018Break; Break

  IT WAS REPORTED BY THE VET THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THREE OR FOUR DAYS POST OP THE VET NOTED A RUPTURE OF THE ABDOMINAL WALL SUTURE. THE KNOTS WERE INTACT. THE ANIMAL HAD A NEW SURGERY FOR EVENTRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320911 ↗

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