Coated VICRYL J841DRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031043244), received between Mar 9, 2021 and Dec 14, 2022 — classified as 19 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF MORE FREQUENT THAN USUAL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15984223 ↗
• MalfunctionDec 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF MORE FREQUENT THAN USUAL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15984222 ↗
• MalfunctionDec 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF MORE FREQUENT THAN USUAL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15984221 ↗
• MalfunctionDec 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF MORE FREQUENT THAN USUAL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15984219 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338751 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338747 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338745 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338730 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338194 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338189 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338177 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338174 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337916 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337904 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337894 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337885 ↗
• MalfunctionJul 8, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE CAME OFF OF THE SUTURE. THE SUTURE IS POPPING OFF THE NEEDLE WHEN THROWING IT THROUGH SKIN/TISSUE. THIS IS ALL THE INFORMATION THAT I HAVE AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136156 ↗
• MalfunctionApr 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAMINECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM (B)(4), THE NEEDLE BROKE. C-ARM WAS UTILIZED TO FIND THE 2-DEGREE PIECE NEEDLE. THE NEEDLE PIECE WAS FOUND IMMEDIATELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635203 ↗
• MalfunctionMar 9, 2021Break

  SUTURE NEEDLE BROKE: ADULT FEMALE PATIENT: LUMBAR LAMINECTOMY & FUSION - AT CLOSING NEEDLE BROKE DURING SUBCUTICULAR-RUNNING CLOSURE - #1 VICRYL FIGURE-OF-8. SUB C DONE W/2-0 VICRYL - 30 QUILL) UTILIZED C-ARM TO FIND THE 2º PIECE - FOUND PIECE IMMEDIATELY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11444309 ↗