Coated VICRYL J497HRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031040632), received between Dec 3, 2019 and Sep 5, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146701 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146674 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146589 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146581 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146574 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146535 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146532 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19854118 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19854052 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19853979 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19853300 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19853298 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19853295 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19853294 ↗
• MalfunctionJul 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT LEAST A DOZEN SUTURES. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. UNKNOWN IF ANY SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19853278 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE POPPED OFF. A SECOND DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. TYPE OF TISSUE BEING SUTURED AT THE TIME OF THE EVENT WAS NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418406 ↗
• MalfunctionDec 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FALLS APART WHEN PULLED FROM PACKAGE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405793 ↗