VICRYL RAPIDE VR416Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031134645), received between Apr 15, 2019 and Jan 17, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE BROKE. A NEW PACKAGE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178229 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. THE VICRYL RAPIDE SNAPPED DURING USE, SNAPPED AT A POINT AWAY FROM THE INSTRUMENT AND KNOT. SNAP WAS NOT EXPECTED AND THERE WAS NO CLEAR REASON AS TO WHY IT SNAPPED IN THE AREA THAT IT DID. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992759 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE SUTURE WOULD TEAR/RIP WHEN THEY WOULD GO TO TIE OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543372 ↗
• MalfunctionSep 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431891 ↗
• MalfunctionSep 1, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406796 ↗
• MalfunctionAug 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322124 ↗
• MalfunctionAug 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EASILY DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465779 ↗
• MalfunctionAug 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NORMAL BIRTH DELIVERY ON (B)(6) 2020 AND SUTURE WAS USED ON THE PERINEAL INCISION. DURING PERINEAL SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. AT THE TIME OF SUTURING, THE WHOLE NEEDLE WAS DEEPLY INSERTED INTO THE TISSUE, THEN, IT WAS BURIED IN THE SUBCUTANEOUS TISSUE. THE SURGEON PULLED THE SUTURE TO REMOVE THE NEEDLE FROM THE TISSUE. AT THAT TIME, THE SUTURE WAS DETACHED FROM THE NEEDLE. SO, THE SURGEON HAD IMPRESSION THAT THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10422236 ↗
• MalfunctionNov 11, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, IT WAS FOUND IN THE INVENTORY THAT THERE WAS INDICATION OF ¿REVERSE CUTTING¿ ON THE BOX THOUGH THE SPEC OF THE NEEDLE SHAPE IS TAPER POINT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306136 ↗
• MalfunctionNov 11, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, IT WAS FOUND IN THE INVENTORY THAT THERE WAS INDICATION OF ¿REVERSE CUTTING¿ ON THE BOX THOUGH THE SPEC OF THE NEEDLE SHAPE IS TAPER POINT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306124 ↗
• MalfunctionNov 11, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, IT WAS FOUND IN THE INVENTORY THAT THERE WAS INDICATION OF ¿REVERSE CUTTING¿ ON THE BOX THOUGH THE SPEC OF THE NEEDLE SHAPE IS TAPER POINT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306123 ↗
• MalfunctionNov 11, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, IT WAS FOUND IN THE INVENTORY THAT THERE WAS INDICATION OF ¿REVERSE CUTTING¿ ON THE BOX THOUGH THE SPEC OF THE NEEDLE SHAPE IS TAPER POINT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306122 ↗
• MalfunctionNov 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING INTERRUPTED SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305126 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515766 ↗
• MalfunctionApr 15, 2019Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515764 ↗