Coated VICRYL J496HRecalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10705031040595), received between Aug 21, 2019 and Oct 10, 2024 — classified as 5 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Material Separation” (87 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 107 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER POCKET CLOSURE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. POST OP OF PROCEDURE, PATIENT CAME IN FOR THEIR SIX WEEK FOLLOW UP CHECK THE SUTURES HAD NOT YET DISSOLVED. SURGEON KEEPING A CLOSE EYE ON IT TO ENSURE INFECTION DOES NOT SET IN. THE PATIENT WAS SENT TO THE PHARMACY FOR A PRESCRIPTION AND WILL BE BACK IN ABOUT A WEEK FOR A NO CHARGE INCISION CHECK. SUTURE WAS USED ON THE OUTER LAYER OF SKIN WITH STERI STRIPS, GAUZE AND THEN A TEGADERM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Purulent Discharge; Unspecified Infection

  MAUDE report 20424426 ↗
• MalfunctionOct 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER POCKET CLOSURE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. POST OP OF PROCEDURE, PATIENT CAME IN FOR THEIR SIX WEEK FOLLOW UP CHECK THE SUTURES HAD NOT YET DISSOLVED. SURGEON KEEPING A CLOSE EYE ON IT TO ENSURE INFECTION DOES NOT SET IN. THE PATIENT HAD TO BE ASSIGNED FOR ATB THERAPY. SUTURE WAS USED ON THE OUTER LAYER OF SKIN WITH STERI STRIPS, GAUZE AND THEN A TEGADERM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 20423128 ↗
• InjuryOct 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER POCKET CLOSURE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. POST OP OF PROCEDURE, PATIENT CAME IN FOR THEIR SIX WEEK FOLLOW UP CHECK THE SUTURES HAD NOT YET DISSOLVED. SURGEON KEEPING A CLOSE EYE ON IT TO ENSURE INFECTION DOES NOT SET IN. NO PRODUCT RETURNING. SUTURE WAS USED ON THE OUTER LAYER OF SKIN WITH STERI STRIPS, GAUZE AND THEN A TEGADERM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Purulent Discharge

  MAUDE report 20365098 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THAT THESE SUTURES ARE SNAPPING OUT OF PATIENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304656 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THAT THESE SUTURES ARE SNAPPING OUT OF PATIENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304497 ↗
• MalfunctionSep 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER POCKET CLOSURE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. POST OP OF PROCEDURE, PATIENT CAME IN FOR THEIR SIX WEEK FOLLOW UP CHECK THE SUTURES HAD NOT YET DISSOLVED. SURGEON KEEPING A CLOSE EYE ON IT TO ENSURE INFECTION DOES NOT SET IN. NO PRODUCT RETURNING. SUTURE WAS USED ON THE OUTER LAYER OF SKIN WITH STERI STRIPS, GAUZE AND THEN A TEGADERM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 20265570 ↗
• MalfunctionSep 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER POCKET CLOSURE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. POST OP OF PROCEDURE, PATIENT CAME IN FOR THEIR SIX WEEK FOLLOW UP CHECK THE SUTURES HAD NOT YET DISSOLVED. SURGEON KEEPING A CLOSE EYE ON IT TO ENSURE INFECTION DOES NOT SET IN. NO PRODUCT RETURNING. SUTURE WAS USED ON THE OUTER LAYER OF SKIN WITH STERI STRIPS, GAUZE AND THEN A TEGADERM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 20265547 ↗
• MalfunctionSep 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER POCKET CLOSURE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. POST OP OF PROCEDURE, PATIENT CAME IN FOR THEIR SIX WEEK FOLLOW UP CHECK THE SUTURES HAD NOT YET DISSOLVED. SURGEON KEEPING A CLOSE EYE ON IT TO ENSURE INFECTION DOES NOT SET IN. NO PRODUCT RETURNING. SUTURE WAS USED ON THE OUTER LAYER OF SKIN WITH STERI STRIPS, GAUZE AND THEN A TEGADERM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 20265525 ↗
• InjurySep 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER POCKET CLOSURE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. POST OP OF PROCEDURE, PATIENT CAME IN FOR THEIR SIX WEEK FOLLOW UP CHECK THE SUTURES HAD NOT YET DISSOLVED. SURGEON KEEPING A CLOSE EYE ON IT TO ENSURE INFECTION DOES NOT SET IN. NO PRODUCT RETURNING. SUTURE WAS USED ON THE OUTER LAYER OF SKIN WITH STERI STRIPS, GAUZE AND THEN A TEGADERM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Impaired Healing

  MAUDE report 20265488 ↗
• MalfunctionMay 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS ISOLATED FROM THE SUTURE WHEN THE SURGEON WANTED TO USE IT. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390564 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18497598 ↗
• MalfunctionJan 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE IS POPPING OFF THE SUTURE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432337 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE POPPED OFF. A SECOND DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. TYPE OF TISSUE BEING SUTURED AT THE TIME OF THE EVENT WAS NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418411 ↗
• MalfunctionDec 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT GENERAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE DURING USE. THIS WAS NOTICED IMMEDIATELY AND THE NEEDLE AND SUTURE WERE DISCARDED. THERE WAS NO DELAY, FRAGMENTS WERE MADE, BUT THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329490 ↗
• MalfunctionDec 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT GENERAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE DURING USE. THIS WAS NOTICED IMMEDIATELY AND THE NEEDLE AND SUTURE WERE DISCARDED. THERE WAS NO DELAY, FRAGMENTS WERE MADE, BUT THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329489 ↗
• MalfunctionNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 23-OCT-2023 AND SUTURE WAS USED. THE NEEDLE IS POPPING OFF THE SUTURE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159556 ↗
• MalfunctionNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 23-OCT-2023 AND SUTURE WAS USED. THE NEEDLE IS POPPING OFF THE SUTURE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159490 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE END OF THE NEEDLE. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067313 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE END OF THE NEEDLE. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067306 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED TO CLOSE SKIN. WHEN PULLING THE SUTURE THROUGH, IT POPPED OFF THE END OF THE NEEDLE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066897 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED TO CLOSE SKIN. WHEN PULLING THE SUTURE THROUGH, IT POPPED OFF THE END OF THE NEEDLE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066889 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF LESION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED IN MULTIPLE AREAS OF THE BODY TO CLOSE THE SKIN. WHILE PULLING THE SUTURE THROUGH THE SKIN TO CONTINUE HIS RUNNING SUTURE, THE NEEDLE POPPED OFF THE SUTURE. A NEW SUTURE WAS PULLED OUT OF THE SAME BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066549 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF LESION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED IN MULTIPLE AREAS OF THE BODY TO CLOSE THE SKIN. WHILE PULLING THE SUTURE THROUGH THE SKIN TO CONTINUE HIS RUNNING SUTURE, THE NEEDLE POPPED OFF THE SUTURE. A NEW SUTURE WAS PULLED OUT OF THE SAME BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066525 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF LESION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED IN MULTIPLE AREAS OF THE BODY TO CLOSE THE SKIN. WHILE PULLING THE SUTURE THROUGH THE SKIN TO CONTINUE HIS RUNNING SUTURE, THE NEEDLE POPPED OFF THE SUTURE. A NEW SUTURE WAS PULLED OUT OF THE SAME BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066514 ↗
• MalfunctionNov 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF LESION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED IN MULTIPLE AREAS OF THE BODY TO CLOSE THE SKIN. WHILE PULLING THE SUTURE THROUGH THE SKIN TO CONTINUE HIS RUNNING SUTURE, THE NEEDLE POPPED OFF THE SUTURE. A NEW SUTURE WAS PULLED OUT OF THE SAME BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066019 ↗