Coated VICRYL J318HRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 17891338030612), received between Oct 10, 2019 and Jan 12, 2024 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL TIMECTOMY SURGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR PROCEEDS TO OPEN 1 ENVELOPE AND AT THE TIME OF CLOSING APONEUROSIS THE TIP OF THE NEEDLE IS BROKEN SO THAT THE SUTURE IS REMOVED AND REPLACED WITH ANOTHER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502506 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT FASCIAL CLOSURE AFTER LAPAROSCOPY ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE BROKE WITHOUT USING EXCESSIVE FORCE. THE PIECE OF NEEDLE WAS FOUND. NO PARTS REMAIN IN THE PATIENT. THE OPERATION WAS CONTINUED AND COMPLETED WITH NEW SUTURES. THERE WAS NO DAMAGE TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287416 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THE NEEDLE BROKE OFF (AFTER 2ND STITCH, SUBCUTANEOUS TISSUE). HAPPENED SEVERAL TIMES WITH DIFFERENT BLISTERS. NEEDLE FELL INTO THE SITUS, WAS IMMEDIATELY RECOVERED. PROCEDURE WAS FINALIZED WITH SAME LIKE PRODUCT. PROCEDURE WAS DELAYED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17818306 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THE NEEDLE BROKE OFF (AFTER 2ND STITCH, SUBCUTANEOUS TISSUE). HAPPENED SEVERAL TIMES WITH DIFFERENT BLISTERS. NEEDLE FELL INTO THE SITUS, WAS IMMEDIATELY RECOVERED. PROCEDURE WAS FINALIZED WITH SAME LIKE PRODUCT. PROCEDURE WAS DELAYED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17817600 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THE NEEDLE BROKE OFF (AFTER 2ND STITCH, SUBCUTANEOUS TISSUE). HAPPENED SEVERAL TIMES WITH DIFFERENT BLISTERS. NEEDLE FELL INTO THE SITUS, WAS IMMEDIATELY RECOVERED. PROCEDURE WAS FINALIZED WITH SAME LIKE PRODUCT. PROCEDURE WAS DELAYED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17817599 ↗
• MalfunctionJan 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. NEEDLES PULLED OFF DURING THE INTRODUCTION OF THE THREAD INSIDE THE TROCAR. TWO NEEDLES FROM THE SAME LOT WERE IMPACTED. ANOTHER THREAD WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237011 ↗
• MalfunctionJan 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. NEEDLES PULLED OFF DURING THE INTRODUCTION OF THE THREAD INSIDE THE TROCAR. TWO NEEDLES FROM THE SAME LOT WERE IMPACTED. ANOTHER THREAD WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237007 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLE PULLED OFF FROM THE THREAD DURING THE PROCEDURE. USE OF ANOTHER LOT, THE PROCEDURE WAS COMPLETED WELL, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023400 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLE PULLED OFF FROM THE THREAD DURING THE PROCEDURE. USE OF ANOTHER LOT, THE PROCEDURE WAS COMPLETED WELL, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023399 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLE PULLED OFF FROM THE THREAD DURING THE PROCEDURE. USE OF ANOTHER LOT, THE PROCEDURE WAS COMPLETED WELL, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023392 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760140 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760129 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759981 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759976 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759973 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759969 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759962 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759959 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759957 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759953 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759947 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759946 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759943 ↗
• MalfunctionNov 9, 2022Material 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 THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759942 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. THE SUTURES BROKE DURING USE AND THE NEEDLE ALSO BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527208 ↗