Coated VICRYL J441HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031039919), received between Aug 21, 2019 and Sep 5, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BOTH SUTURES HAVE BECOME FRAIL AND BREAKING WHEN TYING KNOTS DURING CORONARY ARTERY BYPASS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683264 ↗
• MalfunctionSep 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE AND THREAD SEPARATED AFTER OPENING THE OUTER PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465399 ↗
• MalfunctionAug 23, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357222 ↗
• MalfunctionOct 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, SUTURE NOT ABSORBING LONG AFTER IT IS SUPPOSE TO. THEY CHECKED BACK MONTHS LATER AND STILL FOUND SUTURE. LEAVES STRAYS OF VICRYL ON PATIENT. PRODUCT USED IN CATH LAB. THIS HAS HAPPENED IN MORE THAN ONE CASE WITH MORE THAN ONE PHYSICIAN. IT IS UNKNOWN HOW CASE WAS COMPLETED. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS. NO DEVICE WILL BE RETURNED. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10710886 ↗
• MalfunctionOct 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT PACEMAKER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED TO SUTURE A PACEMAKER POCKET ABOVE THE SUBCLAVIAN VEIN. POST-OP, THE SUTURE WAS IN PLACE FOR 42 DAYS. PUS AND INFLAMMATION WERE OBSERVED AT THE SUTURE SITE AND THE SUTURE HAD NOT DISSOLVED. THE PATIENT WAS NOT FEBRILE AND HAD NO OTHER SYMPTOMS OF INFECTION; CULTURES WERE NOT OBTAINED. THE SUTURE WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation

  MAUDE report 9250878 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8918745 ↗