Coated VICRYL J958HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031043725), received between Jun 13, 2018 and Feb 1, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 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.

• MalfunctionFeb 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE. IT WAS RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277305 ↗
• MalfunctionMay 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISION CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE TIP OF NEEDLE BROKE OFF IN THE NEEDLE HOLDER. THE TIP WAS COLLECTED AND PLACED ON THE MAGNET NEEDLE COUNT BOARD. THE REMAINING NEEDLE AND BROKEN TIP WERE PLACED TOGETHER, IN NEEDLE COUNT BOARD TO ACCOUNT FOR ENTIRE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337080 ↗
• InjuryAug 5, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON UNKNOWN DATE IN 2021 AND THE SUTURE WAS USED. DURING THE PROCEDURE IN THE ABDOMEN, THE NEEDLE SNAPPED IN HALF. X-RAY WAS PERFORMED BUT THE BROKEN NEEDLE WAS UNABLE TO FIND. IT WAS REPORTED THE POTENTIAL NEEDLE LOST IN THE PATIENT¿S ABDOMEN. IT WAS ALSO REPORTED THAT THE PATIENT WILL HAVE A FOLLOW UP SURGERY BUT UNKNOWN DATE, JUST IN THE FUTURE. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12281803 ↗
• MalfunctionJan 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEVED AND FOUND IN THE NEEDLE BOX. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557616 ↗
• MalfunctionDec 31, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THE TIP WAS NOT ABLE TO BE FOUND AND MAY STILL BE IN THE PATIENT. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9534247 ↗
• MalfunctionJun 13, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DISTRIBUTOR RECEIVED A BOX OF SUTURE AND THE BOX WAS CRUSHED. THE DISTRIBUTOR STATED THAT THE PACKAGES INSIDE THE BOX (PRIMARY PACKAGING) WERE DAMAGED AND COULD POSSIBLE AFFECT STERILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597416 ↗