Coated VICRYL VCP423HRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031053113), received between Jan 16, 2020 and Mar 11, 2026 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Degrade” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUTURED PLAN: SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION : ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Impaired Healing; Inflammation; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 24576046 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA SUTURED PLAN: SUBCUTANEOUS IN SEPARATE POINTS RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Pocket Erosion; Wound Dehiscence

  MAUDE report 24571200 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA, SUTURED PLAN: SUBCUTANEOUS IN SEPARATE POINTS, RESORPTION PROBLEM WITH REPEATED INFLAMMATION : ABOUT 5 TO 10% OF PATIENTS, THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE, THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Impaired Healing; Inflammation; Pocket Erosion; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 24571196 ↗
• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS RESULTS IN INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion

  MAUDE report 24484930 ↗
• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS RESULTS IN INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion

  MAUDE report 24484876 ↗
• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS RESULTS IN INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion

  MAUDE report 24484768 ↗
• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS RESULTS IN INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion

  MAUDE report 24484764 ↗
• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS RESULTS IN INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion

  MAUDE report 24484754 ↗
• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS RESULTS IN INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion

  MAUDE report 24484640 ↗
• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS RESULTS IN INFLAMMATION AND REJECTION OF THE WIRE. SUTURE USED ON PTG/PTH/UVC LCA. SUBCUTANEOUS IN SEPARATE POINTS. RESORPTION PROBLEM WITH REPEATED INFLAMMATION: ABOUT 5 TO 10% OF PATIENTS. THE SURGEON HAS NOT CHANGED ANYTHING IN HIS PRACTICE EXCEPT THE SWITCH TO SUTURES MORE. THIS DOES NOT HAPPEN SYSTEMATICALLY BUT IT NOW CONCERNS SEVERAL CASES. IT HAS HAPPENED SEVERAL TIMES SINCE 3 OR 4 MONTHS SO IT IS DIFFICULT TO ESTABLISH WHICH BOX THE THREAD BELONGED TO. ESPECIALLY SINCE IT IS A THREAD THAT IS REGULARLY CONSUMED ON THE ESTABLISHMENT BY SEVERAL SURGEONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion

  MAUDE report 24484542 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED, DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE WAS ALREADY BROKEN OR THE SUTURE WAS ALREADY DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594603 ↗
• MalfunctionAug 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DR WAS ATTEMPTING TO CLOSE A PORT SITE WITH VICRYL SUTURE VCP423, AND HAD TAKEN ONE BITE THROUGH THE TISSUE, WHEN THE NEEDLE BROKE OFF THE SUTURE. THE NEEDLE HAD TO BE RETRIEVED, AND THE SUTURE WAS REMOVED AND SET ASIDE. THIS IS THE FIRST TIME THE SURGEON HAS EXPERIENCED THIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646646 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BREAKS EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16115893 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TWO TO THREE WEEKS POST OP, THE PATIENTS PRESENTED WITH SUTURES EXTRUDING FROM THE BODY AND OPEN WOUNDS. THE SUTURES WERE REMOVED AND WOUND MANAGEMENT INCLUDING ANTIBIOTICS WAS INSTIGATED. THE PATIENT WAS HAVING SUTURE SENSITIVITY AND EXTRUSION OF THE SUTURES. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 15301173 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TWO TO THREE WEEKS POST OP, THE PATIENTS PRESENTED WITH SUTURES EXTRUDING FROM THE BODY AND OPEN WOUNDS. THE SUTURES WERE REMOVED AND WOUND MANAGEMENT INCLUDING ANTIBIOTICS WAS INSTIGATED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 15057195 ↗
• MalfunctionJan 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE LOOSED FROM THE NEEDLE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599487 ↗
• MalfunctionJan 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE LOOSED FROM THE NEEDLE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599486 ↗
• MalfunctionJan 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE LOOSED FROM THE NEEDLE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599485 ↗
• MalfunctionJan 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE LOOSED FROM THE NEEDLE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599484 ↗

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