Coated VICRYL VCP391HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031052918), received between Oct 9, 2023 and Mar 21, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664992 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664351 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664349 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664339 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664336 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664334 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664332 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664327 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370335 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DOWN AFTER SEVERAL DAYS, ESPECIALLY WITH THIS LOT GRADE. OTHER LOT GRADE IS WORKING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370334 ↗
• MalfunctionAug 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APICAL PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHAT HAS HAPPENED/COULD HAVE HAPPENED? DURING APICAL SURGERY, 3 PACKAGES OF SUTURES WERE TAKEN OUT, OF WHICH TWO DETACHED THE NEEDLE FROM THE THREAD. IN ONE CASE, IT HAPPENED ON THE FIRST USE IN THE GINGIVA AND THE OTHER AFTER SOME SUTURES WERE SET. THE SUTURES IN QUESTION ARE VICRYL PLUS 5-0. WHAT INJURY/DISCOMFORT HAS/COULD HAVE BEEN (REPORTER'S COMMENT)? NO HARM OCCURRED AS ANOTHER SUTURE WAS USED AND NEW SUTURES COULD BE PUT. PROBABLE CAUSE (FROM THE REPORTER) DOES NOT KNOW. MANUFACTURING ERRORS? URGENT ACTION TAKEN (RAPPORTEUR'S COMMENT)? IN THE MOMENT, NEW SUTURES WERE BROUGHT OUT. AND THEN A DEVIATION REPORT IS FILED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078595 ↗
• MalfunctionAug 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APICAL PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHAT HAS HAPPENED/COULD HAVE HAPPENED? DURING APICAL SURGERY, 3 PACKAGES OF SUTURES WERE TAKEN OUT, OF WHICH TWO DETACHED THE NEEDLE FROM THE THREAD. IN ONE CASE, IT HAPPENED ON THE FIRST USE IN THE GINGIVA AND THE OTHER AFTER SOME SUTURES WERE SET. THE SUTURES IN QUESTION ARE VICRYL PLUS 5-0. WHAT INJURY/DISCOMFORT HAS/COULD HAVE BEEN (REPORTER'S COMMENT)? NO HARM OCCURRED AS ANOTHER SUTURE WAS USED AND NEW SUTURES COULD BE PUT. PROBABLE CAUSE (FROM THE REPORTER) DOES NOT KNOW. MANUFACTURING ERRORS? URGENT ACTION TAKEN (RAPPORTEUR'S COMMENT)? IN THE MOMENT, NEW SUTURES WERE BROUGHT OUT. AND THEN A DEVIATION REPORT IS FILED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078594 ↗
• MalfunctionOct 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING OR PRIOR THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLES FALL OFF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901570 ↗
• MalfunctionOct 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING OR PRIOR THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLES FALL OFF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901562 ↗

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