Coated VICRYL VCP663HRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031054691), received between May 13, 2024 and Aug 5, 2026 — classified as 23 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147382 ↗
• MalfunctionAug 5, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147381 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFECTION, WHERE CLINICAL ASSESSMENT INDICATES THAT THE SURGICAL WOUND WAS IN GOOD CONDITION, HOWEVER, THERE WAS DELAYED WOUND HEALING WHICH APPEARED TO BE ASSOCIATED WITH THE TYPE OF SUTURE MATERIAL USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Itching Sensation; Purulent Discharge; Unspecified Infection

  MAUDE report 25284045 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFECTION, WHERE CLINICAL ASSESSMENT INDICATES THAT THE SURGICAL WOUND WAS IN GOOD CONDITION, HOWEVER, THERE WAS DELAYED WOUND HEALING WHICH APPEARED TO BE ASSOCIATED WITH THE TYPE OF SUTURE MATERIAL USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Itching Sensation; Purulent Discharge; Unspecified Infection

  MAUDE report 25283914 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INCISION COMPLICATION AND REQUIRED INCISION PACKING. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24729468 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND INFECTION AND WAS STARTED ON ANTIBIOTICS. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 24729459 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INCISION COMPLICATION AND REQUIRED INCISION PACKING. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24727957 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND INFECTION AND WAS STARTED ON ANTIBIOTICS. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 24727952 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND INFECTION AND WAS STARTED ON ANTIBIOTICS. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 24727237 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INCISION COMPLICATION AND REQUIRED INCISION PACKING. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24727200 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND INFECTION AND WAS STARTED ON ANTIBIOTICS. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 24727191 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INCISION COMPLICATION AND REQUIRED INCISION PACKING. THE PATIENT MAY HAVE HAD A WOUND DEHISCENCE AND THE SUTURE PROTRUDING FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24727097 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 3 ACTUAL PRODUCTS FOR ANALYSIS. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442678 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 3 ACTUAL PRODUCTS FOR ANALYSIS. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442676 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 3 ACTUAL PRODUCTS FOR ANALYSIS. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442674 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413418 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413414 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413413 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413412 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413340 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL OF TWO PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241277 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL OF TWO PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241159 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240016 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY . TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT . NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240009 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. TOTAL OF 4 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228750 ↗

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