VICRYL RAPIDE VR493Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031134676), received between Jul 11, 2019 and Nov 13, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543654 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543652 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543648 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543647 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536293 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK: BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536292 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535836 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535835 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535650 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535649 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535636 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT STRUCTURAL INTEGRITY OF SUTURE IS TOO WEAK - BREAKS TOO EASILY AND IS NEAR IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535627 ↗
• MalfunctionOct 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360345 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 26/02/2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944004 ↗
• MalfunctionMay 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE CAME OFF. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238075 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE MATERIAL JUST BREAKS AND YOU CAN'T EVEN TIE A KNOT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579360 ↗
• MalfunctionMar 24, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED WHILE PULLING THROUGH TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11560454 ↗
• MalfunctionMar 24, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED WHILE PULLING THROUGH TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11560413 ↗
• MalfunctionApr 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RECTAL RESECTION ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986367 ↗
• MalfunctionDec 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. THE SUTURES SEPARATING EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468122 ↗
• MalfunctionOct 1, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE OFF DURING USE OF THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9140678 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE DOCTOR WENT TO TIE IT. A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869683 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE DOCTOR WENT TO TIE IT. A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869682 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE DOCTOR WENT TO TIE IT. A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869679 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE DOCTOR WENT TO TIE IT. A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869678 ↗