Coated VICRYL J774DRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031042919), received between May 13, 2019 and Apr 20, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THE NEEDLES ARE DETACHING FROM THE SUTURES. NO OTHER INFORMATION THAT WAS PROVIDED. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927873 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN AFTER SUTURING. IT IS CURRENTLY UNKNOWN WHEN THE NEEDLE WAS BROKEN. THE BROKEN NEEDLE THAT FELL INSIDE THE PATIENT'S BODY WAS RETRIEVED. THERE WAS NO EFFECT ON THE PATIENT. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927342 ↗
• MalfunctionJan 7, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN OPENING THE BOX, THERE WERE ONLY 11 PACKAGES IN IT. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995760 ↗
• MalfunctionJul 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOW PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING INTERRUPTED SUTURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE BEGINNING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711260 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE BROKE AT THE SWAGE PART DURING USE. THE PRODUCT WAS NOT USED TO SUTURE HARD TISSUE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18820299 ↗
• MalfunctionFeb 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6)2024, AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROFESSIONAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778830 ↗
• MalfunctionFeb 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROFESSIONAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778823 ↗
• MalfunctionFeb 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROFESSIONAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778817 ↗
• MalfunctionMar 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OTOLARYNGOLOGY/HEAD AND NECK SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521402 ↗
• MalfunctionFeb 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. THIS HAPPENED IN 3 PACKAGES IN A ROW AND ALL PACKAGES HAD THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301734 ↗
• MalfunctionFeb 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. THIS HAPPENED IN 3 PACKAGES IN A ROW AND ALL PACKAGES HAD THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301343 ↗
• MalfunctionFeb 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. THIS HAPPENED IN 3 PACKAGES IN A ROW AND ALL PACKAGES HAD THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301311 ↗
• MalfunctionJan 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, WHEN CHECKING THE SUTURES AFTER THE PACKAGE WAS OPENED, A MONOFILAMENT APPEARED TO BE MIXED IN THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13185930 ↗
• MalfunctionJan 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, WHEN CHECKING THE SUTURES AFTER THE PACKAGE WAS OPENED, A MONOFILAMENT APPEARED TO BE MIXED IN THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13185923 ↗
• MalfunctionJan 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, WHEN CHECKING THE SUTURES AFTER THE PACKAGE WAS OPENED, A MONOFILAMENT APPEARED TO BE MIXED IN THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13185858 ↗
• MalfunctionJan 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, WHEN CHECKING THE SUTURES AFTER THE PACKAGE WAS OPENED, A MONOFILAMENT APPEARED TO BE MIXED IN THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13185847 ↗
• MalfunctionJan 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, WHEN CHECKING THE SUTURES AFTER THE PACKAGE WAS OPENED, A MONOFILAMENT APPEARED TO BE MIXED IN THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13185792 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF AT THE SWAGE PART WHEN TRYING TO DETACH THE NEEDLE FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017773 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, TWO SUTURES GOT DETACHED FROM THE NEEDLE EASILY DURING USE, AND DURING LIGATION, SUTURE BREAKAGE OCCURRED FIVE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615254 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, TWO SUTURES GOT DETACHED FROM THE NEEDLE EASILY DURING USE, AND DURING LIGATION, SUTURE BREAKAGE OCCURRED FIVE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615250 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, TWO SUTURES GOT DETACHED FROM THE NEEDLE EASILY DURING USE, AND DURING LIGATION, SUTURE BREAKAGE OCCURRED FIVE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615245 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, TWO SUTURES GOT DETACHED FROM THE NEEDLE EASILY DURING USE, AND DURING LIGATION, SUTURE BREAKAGE OCCURRED FIVE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615244 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, TWO SUTURES GOT DETACHED FROM THE NEEDLE EASILY DURING USE, AND DURING LIGATION, SUTURE BREAKAGE OCCURRED FIVE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615241 ↗
• MalfunctionApr 5, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, TWO SUTURES GOT DETACHED FROM THE NEEDLE EASILY DURING USE, AND DURING LIGATION, SUTURE BREAKAGE OCCURRED FIVE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615239 ↗
• MalfunctionApr 5, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, TWO SUTURES GOT DETACHED FROM THE NEEDLE EASILY DURING USE, AND DURING LIGATION, SUTURE BREAKAGE OCCURRED FIVE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615238 ↗