Coated VICRYL VCP726DRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031055117), received between Jul 22, 2019 and Jun 11, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHRECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A LAPAROSCOPIC NEPHRECTOMY, IT WAS FOUND THAT THE SUTURE HAS FRAYED DURING USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470595 ↗
• InjuryJun 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS BROUGHT BACK TO THE OR WITH WOUND DEHISCENCE OF THE ENTIRE WOUND CLOSURE. WOUND WAS IRRIGATED THEN RECLOSED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22124478 ↗
• InjuryJun 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS BROUGHT BACK TO THE OR WITH WOUND DEHISCENCE OF THE ENTIRE WOUND CLOSURE. WOUND WAS IRRIGATED THEN RECLOSED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22124358 ↗
• InjuryMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS BROUGHT BACK TO THE OR WITH WOUND DEHISCENCE OF THE ENTIRE WOUND CLOSURE. WOUND WAS IRRIGATED THEN RECLOSED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22031152 ↗
• MalfunctionAug 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923413 ↗
• MalfunctionSep 28, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE SIZE ON THE PACKAGE IS DIFFERENT. THE NEEDLE SIZE ON THE ARTWORK ALSO APPEARS TO BE DIFFERENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834657 ↗
• MalfunctionAug 24, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY, ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS NOTED THE NEEDLE SIZE INDICATED ON THE PACKAGE SHOULD USUALLY BE WRITTEN AS 26 MM, BUT IT WAS WRITTEN AS 27 MM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288476 ↗
• MalfunctionMay 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF COMMINUTED FRACTURE OF LEFT TIBIAL PLATEAU SURGERY, PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES WERE USED CONTINUOUSLY. WHEN THE NEEDLE PASSED THROUGH THE TISSUE BUT THE SUTURE DID NOT PASS THROUGH THE TISSUE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE SUTURED NORMALLY. THEN ANOTHER SUTURE OF THE SAME BATCH NUMBER WAS USED AND THE SUTURE WAS SMOOTH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489166 ↗
• MalfunctionMay 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF COMMINUTED FRACTURE OF LEFT TIBIAL PLATEAU SURGERY, PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES WERE USED CONTINUOUSLY. WHEN THE NEEDLE PASSED THROUGH THE TISSUE BUT THE SUTURE DID NOT PASS THROUGH THE TISSUE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE SUTURED NORMALLY. THEN ANOTHER SUTURE OF THE SAME BATCH NUMBER WAS USED AND THE SUTURE WAS SMOOTH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489161 ↗
• MalfunctionJun 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, IT WAS NOTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED. TWO HOLES WERE FOUND ON THE PACKAGE BEFORE OPENING THE PACKAGE. STERILITY WAS COMPROMISED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044702 ↗
• MalfunctionJan 13, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THE INDICATION OF THE NEEDLE SIZE ON THE PACKAGE WAS ¿CT-2, 27MMM¿ WHICH IS NOT CORRECT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168475 ↗
• MalfunctionApr 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PACKET OF SUTURE WAS MIXED INTO A BOX OF A DIFFERENT SUTURE. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998949 ↗
• MalfunctionApr 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PACKET OF SUTURE WAS MIXED INTO A BOX OF A DIFFERENT SUTURE. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998948 ↗
• MalfunctionJul 22, 2019Inaccurate Information; Inaccurate Information

  IT WAS REPORTED PRIOR TO UNKNOWN PROCEDURE ON (B)(6) 2019 SUTURE WAS USED. IT WAS NOTED THAT THE INFORMATION WAS INCONSISTENT BETWEEN INSIDE AND OUTSIDE PACKAGE. THE LABELING ON THE OUTER STERILE PACKAGE IS LABELED AS 26MM, BUT INSIDE PAPER LID IS LABELED AS 27MM. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813055 ↗

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