Coated VICRYL VCP496HRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031053786), received between May 13, 2020 and Apr 21, 2025 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Material Separation” (22 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025 AND SUTURE WAS USED. THERE WAS A BLACK DOT ON THE SUTURE WHILE THE NURSE JUST OPENED THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878388 ↗
• MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS A BLACK DOT ON THE SUTURE WHILE THE NURSE JUST OPENED THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878387 ↗
• MalfunctionDec 27, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS FRAYED, SO THEY OPENED MULTIPLE DEVICES OF THE SAME PRODUCT CODE AND LOT NUMBER. 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 16056102 ↗
• MalfunctionAug 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE COMES OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196246 ↗
• MalfunctionJul 1, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2022 AND SUTURE WAS USED. THE PATIENT WAS DIAGNOSED WITH COVID-19 SO THE HEALTHCARE PROFESSIONALS WORE THE PPE TO PERFORM THE PROCEDURE. WHEN HCP PERFORMED WOUND CLOSURE, NEEDLE BREAKAGE OCCURRED AND FALL WAS NOTED. THE SURGEON OPINED THAT UNDER TIGHT TIMEFRAMES, WEARING PPE MAY HAVE CAUSED DEVIATION ON THE FORCES/POINT ACTING ON A NEEDLE DURING OPERATION. CONSIDERED THAT TIGHT TIMEFRAMES AND SPECIAL COVID-19 CASE, HCPS DECIDED TO STITCH UP A WOUND FIRST, AND THEN PERFORM X-RAYS TO LOCALIZE THE NEEDLE, AND REMOVE ALL RETAINED NEEDLE PIECE FROM THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO IMPACT ON EFFECTIVENESS OF SURGERY. PATIENT IS FINE. NO NEGATIVE OUTCOME WAS FOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887354 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR/ BATTERY CHANGE OF A DEFIBRILLATOR PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING USE, THE SUTURE KEPT BREAKING. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849178 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR/BATTERY CHANGE OF A DEFIBRILLATOR PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING USE, THE SUTURE KEPT BREAKING. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849176 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR/BATTERY CHANGE OF A DEFIBRILLATOR PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING USE, THE SUTURE KEPT BREAKING. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849165 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249941 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249933 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249925 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249923 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249905 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249862 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249845 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249785 ↗
• MalfunctionJul 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249770 ↗
• MalfunctionJul 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED CARDIAC PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD THE NEEDLE 'POP OFF'. A NEW LIKE SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177603 ↗
• MalfunctionJul 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED CARDIAC PROCEDURE ON 06/21/2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD THE NEEDLE 'POP OFF'. A NEW LIKE SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177595 ↗
• MalfunctionJul 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED CARDIAC PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD THE NEEDLE 'POP OFF'. A NEW LIKE SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177556 ↗
• MalfunctionJul 15, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DAVINCI ADRENALECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES DEBRAIDED AND DISINTEGRATED WHILE TYING. 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 12174282 ↗
• MalfunctionJul 15, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DAVINCI ADRENALECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES DEBRAIDED AND DISINTEGRATED WHILE TYING. 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 12174274 ↗
• MalfunctionJul 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. 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 12159017 ↗
• MalfunctionFeb 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE THREAD BROKE OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297897 ↗
• MalfunctionFeb 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE THREAD BROKE OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297861 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and