Coated VICRYL J346HRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10705031039117), received between Apr 29, 2019 and Jan 22, 2026 — classified as 1 injury, 92 malfunctions.

The most frequently reported specific device problem is “Material Separation” (50 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE ON TWO DIFFERENT CASES. THE SURGEON WAS CLOSING THE UTERINE CAVITY. THE NEEDLE TIP BROKE OFF WHILE SUTURING AND WE WERE UNABLE TO LOCATE THE NEEDLE TIP. THEY HAD TO PERFORM AN ABDOMINAL X-RAY TO CONFIRM THERE WAS NO FOREIGN BODY. THE SECOND TIME THE NEEDLE TIP BROKE OFF, THE NEEDLE WAS PLACED IN THE NEEDLE COUNTER AND PROCEEDED TO BREAK OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147875 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE ON TWO DIFFERENT CASES. THE SURGEON WAS CLOSING THE UTERINE CAVITY. THE NEEDLE TIP BROKE OFF WHILE SUTURING AND WE WERE UNABLE TO LOCATE THE NEEDLE TIP. THEY HAD TO PERFORM AN ABDOMINAL X-RAY TO CONFIRM THERE WAS NO FOREIGN BODY. THE SECOND TIME THE NEEDLE TIP BROKE OFF, THE NEEDLE WAS PLACED IN THE NEEDLE COUNTER AND PROCEEDED TO BREAK OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147874 ↗
• MalfunctionJul 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD BECAME SEPARATED FROM THE NEEDLE. THERE WAS NO HARM ON PATIENT. HAPPENED DURING REPAIR OF THE UTERUS. THE SUTURE WAS REPLACED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663758 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN CLOSING THE FASCIA ON THE PATIENT THE NEEDLE WAS BLUNT INCISION CLOSURE WAS STOP THE NEEDLE POINT BROKE OFF. XRAY WAS NEGATIVE FOR ANY FOREIGN MATERIALS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513136 ↗
• MalfunctionJul 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE POPPED OFF DURING SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396576 ↗
• MalfunctionApr 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904099 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, PROCEDURE THE SUTURE WOULD START TO DISSOLVE WITH IN DAYS CREATING WOUND DEHISCE. ANIMAL CURRENTLY DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21754582 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED A ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, PROCEDURE THE SUTURE WOULD START TO DISSOLVE WITH IN DAYS CREATING WOUND DEHISCE. ANIMAL CURRENTLY DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21753327 ↗
• MalfunctionFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN OPEN GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE IN 2025 AND SUTURE WAS USED. THE NEEDLE HAD DETACHED DIRECTLY FROM THE SUTURE WITHOUT STRONG TRACTION WHEN PULLING THROUGH THE TISSUE. THE OPERATION WAS CONTINUED AND COMPLETED AS PLANNED USING SUTURES FROM A DIFFERENT BATCH. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. NO USED SUTURES WERE RETAINED, BUT DISCARDED DIRECTLY INTRA-OPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457810 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN OPEN GYNECOLOGICAL PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. ONCE THE NEEDLE BROKE WITHOUT EXCESSIVE FORCE; THE BROKEN PIECE COULD BE RECOVERED. THE OPERATION WAS CONTINUED AND COMPLETED AS PLANNED USING SUTURES FROM A DIFFERENT BATCH. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. NO USED SUTURES WERE RETAINED, BUT DISCARDED DIRECTLY INTRA-OPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457681 ↗
• MalfunctionFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN OPEN GYNECOLOGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HAD DETACHED DIRECTLY FROM THE SUTURE WITHOUT STRONG TRACTION WHEN PULLING THROUGH THE TISSUE. THE OPERATION WAS CONTINUED AND COMPLETED AS PLANNED USING SUTURES FROM A DIFFERENT BATCH. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. NO USED SUTURES WERE RETAINED, BUT DISCARDED DIRECTLY INTRA-OPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457680 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING FROM THE CUSTOMER THAT THE NEEDLE HAD CAME OFF OF THE SUTURE TWICE. NO PATIENT HARM REPORTED AND NO ADDITIONAL INFORMATION GIVEN TO REP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504511 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING FROM THE CUSTOMER THAT THE NEEDLE HAD CAME OFF OF THE SUTURE TWICE. NO PATIENT HARM REPORTED AND NO ADDITIONAL INFORMATION GIVEN TO REP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504510 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. SURGEON SUTURING WOUND BED CLOSED AND SECOND NEEDLE BROKE DURING USE AND LODGED INTO PATIENT'S TISSUE; WAS SEARCHED FOR AND RECOVERED FROM PATIENT'S BACK. ALL PIECES ACCOUNTED FOR AND NONE LEFT IN PATIENT. ALL PIECES ACCOUNTED FOR AND REMOVED FROM STERILE FIELD. NO OTHER DETAILS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263883 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. SURGEON SUTURING WOUND BED CLOSED AND NEEDLE BROKE DURING USE. FIRST SUTURE NEEDLE FELL TO FLOOR WHEN BROKEN AND WAS RECOVERED. ALL PIECES ACCOUNTED FOR AND NONE LEFT IN PATIENT. ALL PIECES ACCOUNTED FOR AND REMOVED FROM STERILE FIELD. NO OTHER DETAILS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263882 ↗
• MalfunctionAug 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES HAVE NEEDLE "POPPING OFF" OF SUTURE TOO EASILY FOR 2 DIFFERENT SURGEONS IN THE BIRTHING CENTER. ALMOST LIKE IT WAS A CODE OF OUR "POP OFF NEEDLES". THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065644 ↗
• MalfunctionAug 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES POPPED OFF NEEDLE INTRA OP DURING UTERINE CLOSURE FROM C SECTION.THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065621 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026850 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026681 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018391 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017954 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016260 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. THIS HAS HAPPENED REPEATEDLY SINCE LAST WEEK 6-8 TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015575 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013462 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT APPEARS THAT THE THREAD COMES OFF THE NEEDLE EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013284 ↗