Coated VICRYL VCP946H (UDI 10705031056145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705031056145), received between Jan 17, 2018 and Mar 12, 2026 — classified as 18 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN BEING USED. SURGICAL DELAY WAS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584544 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN BEING USED. SURGICAL DELAY WAS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584542 ↗
• MalfunctionFeb 26, 2026

  DURING CESAREAN SECTION 0 VICRYL CT-1 SUTURE NEEDLE TIP FRACTURED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454806 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949719 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949696 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949690 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949673 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949670 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949662 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949660 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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, POST-OP, DURING A FOLLOW UP VISIT, THE DOCTOR FOUND INFECTION ON THE SUTURED SITE. THE DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949641 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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, POST-OP, DURING A FOLLOW UP VISIT, THE DOCTOR FOUND INFECTION ON THE SUTURED SITE. THE DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949624 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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, POST-OP, DURING A FOLLOW UP VISIT, THE DOCTOR FOUND INFECTION ON THE SUTURED SITE. THE DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949620 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOIT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED, POST-OP, DURING A FOLLOW UP VISIT, THE DOCTOR FOUND INFECTION ON THE SUTURED SITE. THE DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949619 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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, POST-OP, DURING A FOLLOW UP VISIT, THE DOCTOR FOUND INFECTION ON THE SUTURED SITE. THE DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949610 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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, POST-OP, DURING A FOLLOW UP VISIT, THE DOCTOR FOUND INFECTION ON THE SUTURED SITE. THE DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949602 ↗
• MalfunctionMay 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. DURING A C-SECTION PROCEDURE THAT THE SUTURE STRAIN BROKE IN MULTIPLE PLACES AS THE MD WAS PREFORMING THE CLOSURE. NO PATIENT CONSEQUENCES WERE REPORTED. THE BOX WAS REMOVED FROM THE OR AND REPLACED WITH ANOTHER BOX. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003160 ↗
• MalfunctionApr 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE PER USER FACILITY MEDWATCH FORM, MW 3901330000-2022-8048, WHILE SUTURING THE UTERUS CLOSED THE NEEDLE SNAPPED OFF ONLY LEAVING A VERY SMALL PIECE ATTACHED TO THE SUTURE. THE RESIDENT SUTURE IMMEDIATELY STOPPED. AND THE ATTENDING PHYSICIAN VERIFIED THAT THE NEEDLE NOT INTACT. THE IMMEDIATE SURGICAL AREA WAS SEARCHED WITHOUT SUCCESS. THE FLOOR SURROUNDING THE PATIENT WAS SEARCHED WITHOUT SUCCESS. XRAY AND ULTRASOUND WERE CONTACTED TO COME TO THE BEDSIDE STAT. A MAGNET WAS BROUGHT UP FROM THE MAIN OR TO CHECK THE FLOOR SURROUNDING THE PATIENT BUT WAS UNSUCCESSFUL. PATIENT RECEIVED XRAY WHICH SHOWED THAT THE PIECE OF THE NEEDLE WAS IN THE UTERINE WALL. ULTRASOUND WAS DONE TEN MINUTES LATER TO LOCATE EXACTLY WHERE THE NEEDLE WAS. NEEDLE WAS REMOVED IMMEDIATELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16811993 ↗
• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING SURGERY, WHILE PUTTING A STITCH IN THE CERVIX AND THE NEEDLE BROKE. RETRIEVED BOTH THE HALF OF THE NEEDLE ON THE NEEDLE HOLDER AND THE OTHER HALF IN THE CERVIX ¿ WHICH WAS TAKEN OUT WITH THE UTERUS DURING SURGERY. NO HARM TO PATIENT JUST DEFECTIVE NEEDLE. ALL OF THE NEEDLE WAS FOUND AND EXAMINED TO MAKE SURE IT WAS FULLY RETRIEVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16609411 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLD KNIFE CONE BIOPSY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN PASSING THE NEEDLE THROUGH THE CERVIX THE TIP BROKE OFF. IT HAD COME IN CONTACT WITH THE GRASPER WHILE THE RESIDENT SUTURED. IT WAS NOT RETRIEVED AND COULD NOT BE LOCATED WITH X-RAY. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849957 ↗
• MalfunctionAug 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF WHILE SUTURING INTERNAL TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152296 ↗
• MalfunctionJun 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. WHEN THE SUTURE WAS OPENED, THE NEEDLE PREMATURELY POPPED OFF NEAR THE END. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654493 ↗
• MalfunctionMar 12, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE ARE FRAYED AND ARE BREAKING WHILE SUTURING. AN UNKNOWN INJURY OR ADVERSE EVENT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13744296 ↗
• MalfunctionDec 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6), 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, A SMALL PIECE OF THE NEEDLE BROKE OFF IN THE PATIENT. CHANGED 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 13043456 ↗
• InjuryDec 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AND THE WOUND WAS OPENED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13025487 ↗

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