Coated VICRYL J740DRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031042636), received between Jan 25, 2018 and Aug 5, 2025 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT 3 NEEDLES IN AN 8 PACK CONTROL RELEASE EACH POPPED OFF WHEN A SURGEON WAS NOT INTENDING TO RELEASE THE NEEDLE. SAME LOT IS ON THE SHELF AND WAS GIVEN PERMISSION TO SEND A SAMPLE BACK. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS THERE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716007 ↗
• MalfunctionAug 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT 3 NEEDLES IN AN 8 PACK CONTROL RELEASE EACH POPPED OFF WHEN A SURGEON WAS NOT INTENDING TO RELEASE THE NEEDLE. SAME LOT IS ON THE SHELF AND WAS GIVEN PERMISSION TO SEND A SAMPLE BACK. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS THERE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715982 ↗
• MalfunctionAug 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT 3 NEEDLES IN AN 8 PACK CONTROL RELEASE EACH POPPED OFF WHEN A SURGEON WAS NOT INTENDING TO RELEASE THE NEEDLE. SAME LOT IS ON THE SHELF AND WAS GIVEN PERMISSION TO SEND A SAMPLE BACK. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS THERE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715924 ↗
• MalfunctionMay 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE PRODUCT WAS PULLED OUT FROM THE SOT CASE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270039 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. SUTURE POP OFFS THAT THEY USED WERE CAUSING ISSUES. A PACK WITH THE SAME LOT CODE WERE DISCONNECTING TOO EASILY OFF TOO. PRODUCT IS NOT AVAILABLE FOR RETURN. PROCEDURE WAS COMPLETED. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781887 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. SUTURE POP OFFS THAT THEY USED WERE CAUSING ISSUES. A PACK WITH THE SAME LOT CODE WERE DISCONNECTING TOO EASILY OFF TOO. PRODUCT IS NOT AVAILABLE FOR RETURN. PROCEDURE WAS COMPLETED. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781881 ↗
• MalfunctionJul 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS IMMEDIATELY DETACHED FROM THE NEEDLE AND COULD NOT BE USED. IT WAS 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 17370985 ↗
• MalfunctionJul 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS IMMEDIATELY DETACHED FROM THE NEEDLE AND COULD NOT BE USED. IT WAS 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 17370982 ↗
• MalfunctionMay 23, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. HAIR WAS FOUND IN A NEW SUTURE PACKING MAKING IT UNSTERILE. THE PACKAGE WAS OPENED DURING SURGERY, MADE IT ONTO THE FIELD, BUT WAS NOT USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986894 ↗
• MalfunctionMay 17, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A HAIR FOUND IN NEW SUTURE PACK, MADE UNSTERILE BY HAIR. OPENED DURING SURGERY, NOT USED ON PATIENT BUT MADE IT ONTO FIELD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946812 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED ON THE MYOMETRIUM. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN WITH USE. THE NEEDLE WAS BROKEN BECAUSE THE NEEDLE TIP WAS HELD. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGERY WITHOUT ADDITIONAL PROCEDURE AND IT WAS NEVER MISSING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814180 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN PULLING OUT THE NEEDLE AFTER PASSING THE NEEDLE THROUGH THE TISSUE. THIS ISSUE OCCURRED IN 3 SUTURES IN A ROW. THEY WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766150 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN PULLING OUT THE NEEDLE AFTER PASSING THE NEEDLE THROUGH THE TISSUE. THIS ISSUE OCCURRED IN 3 SUTURES IN A ROW. THEY WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766148 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN PULLING OUT THE NEEDLE AFTER PASSING THE NEEDLE THROUGH THE TISSUE. THIS ISSUE OCCURRED IN 3 SUTURES IN A ROW. THEY WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766147 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE TIP WAS BROKEN. AFTER THAT, THE BROKEN PIECE WAS FOUND. THE SURGEON RECOGNIZES THERE IS A POSSIBILITY THAT THE SURGEON OR A NURSE MAY HAVE PUT PRESSURE ON THE NEEDLE TIP WHEN HOLDING THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14297673 ↗
• MalfunctionJun 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING THE FIRST PASS THE NEEDLE WAS POPPING OFF THE SWEG TOO EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE SUTURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028782 ↗
• MalfunctionJun 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. WITH THE PASSING OF THE SECOND STRAND THE NEEDLE BROKE OFF THE SWEG. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE SUTURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028774 ↗
• MalfunctionJun 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING USE, THE NEEDLE WAS POPPING OFF THE SWEG TOO EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE SUTURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028769 ↗
• MalfunctionJun 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING USE, THE NEEDLE WAS POPPING OFF THE SWEG TOO EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE SUTURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028766 ↗
• MalfunctionDec 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068707 ↗
• MalfunctionDec 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068704 ↗
• MalfunctionDec 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2020 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING INTERRUPTED SUTURING ON THE MYOMETRIUM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987905 ↗
• MalfunctionAug 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS BROKEN AT THE SWAGE PART. AT THAT TIME, THE NEEDLE WAS HELD AT THE SWAGE PART. NO PIECES FELL INTO THE PATIENT¿S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420873 ↗
• MalfunctionApr 27, 2020Material Separation; Material Separation

  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 PULLED OFF THE NEEDLE DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000703 ↗
• MalfunctionApr 27, 2020Material Separation; Material Separation

  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 PULLED OFF THE NEEDLE DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000691 ↗