Coated VICRYL VCP421HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031053076), received between May 30, 2019 and Aug 25, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441411 ↗
• MalfunctionAug 4, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129770 ↗
• MalfunctionApr 28, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AND THYROID SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION, THERE WERE ISSUES WITH THE QUALITY OF THE SUTURE, RESULTING IN THE BREAKAGE AND DRAWING OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017788 ↗
• MalfunctionMay 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. ON THE MORNING, THE PARTURIENT UNDERWENT SURGERY DUE TO BREECH PRESENTATION. WHEN USING SUTURE FOR SUTURING, THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE SUDDENLY HAPPENED. IMMEDIATELY REPLACED IT WITH A NEW ONE AND SUTURED AGAIN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073719 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER OPENING AND USING THE SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND A NEW PRODUCT WAS USED AS A REPLACEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945640 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS SUTURING THE PATIENT'S SKIN, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079570 ↗
• InjuryJan 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WITH SUTURING THE HYSTEROMYOMA, RESULTING IN INCISION BLEEDING, AND THE SEW WAS NOT IN PLACE. THE TREATMENT EFFECT WAS POOR. THE BLEEDING SITE OF THE TISSUE WAS URGENTLY TREATED IMMEDIATELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13230190 ↗
• MalfunctionAug 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOOTH EXTRACTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385956 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE FRONT HALF OF THE NEEDLE REMAINED IN THE TISSUE, BUT IT WAS REMOVED FROM THE TISSUE BY TWEEZERS LATER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11030297 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN WHEN SEWING THE LAST LAYER OF SKIN. THE BROKEN NEEDLE WAS TAKEN OUT FROM THE SKIN. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THE PATIENT¿S INCISION RECOVERED WELL BEFORE DISCHARGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125606 ↗
• MalfunctionMay 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING THE SKIN. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656436 ↗

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