Coated VICRYL VCP486H (UDI 10705031053618)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705031053618), received between Jan 16, 2020 and Apr 1, 2026 — classified as 5 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AS DR WAS SUTURING, THE NEEDLE TIP BROKE OFF. BECAUSE DR COULDN'T SEE ANY BROKEN NEEDLE TIP FRAGMENT IN THE PATIENT, HE DECIDED NOT TO DO AN X-RAY. THEY OPENED ANOTHER SUTURE (WHICH WAS OK) AND CONTINUED WITH THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756623 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. I HAVE RECEIVED A MESSAGE FROM ONE OF OUR CUSTOMERS REGARDING SUTURE. THEY HAVE RECEIVED COMPLAINTS THAT THIS SUTURE IS CONSTANTLY BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237094 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. I HAVE RECEIVED A MESSAGE FROM ONE OF OUR CUSTOMERS REGARDING SUTURE. THEY HAVE RECEIVED COMPLAINTS THAT THIS SUTURE IS CONSTANTLY BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237077 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLE TIP OF SUTURE BROKE OFF DURING SURGERY. USED DURING ORTHOPEDIC SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190255 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NURSING MANAGER DESCRIBED AS BROKEN SUTURE NEEDLE TIPS, WITH MISSING TIPS IN 2 SEPARATE OCCASIONS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778832 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY REPLACEMENT ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE BROKE DURING PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042008 ↗
• MalfunctionJun 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE PULLED AWAY FROM THE THREAD DURING SURGERY. ANOTHER SUTURE WAS OPENED, AND THE SAME INCIDENT OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466277 ↗
• MalfunctionJun 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE PULLED AWAY FROM THE THREAD DURING SURGERY. ANOTHER SUTURE WAS OPENED, AND THE SAME INCIDENT OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466273 ↗
• MalfunctionNov 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. SEPARATION OF NEEDLES AND THREADS DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057373 ↗
• MalfunctionNov 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. SEPARATION OF NEEDLES AND THREADS DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057322 ↗
• InjurySep 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS ALSO REPORTED THAT INITIAL PFANNENSTIEL FASCIA CLOSURE ON (B)(6) 2023 WAS DONE WITH SUTURE. POST-OP, THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2023, A WEEK AFTER THE CAESAREAN SECTION WAS DONE, WITH WOUND DEHISCENCE. THE PATIENT REPORTED BLEEDING. WHEN THE PATIENT WENT BACK TO THE OR, A BROKEN SUTURE WAS NOTED. ADDITIONAL INFORMATION, INCLUDING CLARIFICATION OF DATES, HAS BEEN REQUESTED.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 17799169 ↗
• InjurySep 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED FOR PFANNENSTIEL FASCIA CLOSURE . SIX DAYS POST-OP, THE PATIENT REPORTED DISCOMFORT. THE PATIENT RETURNED TO THE OPERATING ROOM WITH WOUND DEHISCENCE. DURING THE RE-OPERATION, THE ABDOMEN WAS RINSED OUT. THE SUTURE WAS REMOVED AND THE FASCIA WAS CLOSED WITH A DIFFERENT SUTURE. THE SUBCUTANEOUS AND SUBCUTICULAR CLOSURE WAS SUBSEQUENTLY DONE. UPON THE RE-OPERATION, IT WAS FOUND THAT THE KNOTS WERE INTACT TO THE LEFT AND RIGHT BUT THE SUTURE WAS BROKEN MORE OR LESS IN THE MIDDLE OF THE CLOSURE. THE PATIENT IS CURRENTLY IN GOOD HEALTH AND RECOVERING WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Wound Dehiscence

  MAUDE report 17785067 ↗
• MalfunctionAug 2, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE SURGEON COMPLAINT ABOUT THE VCP486H IN NEW PACKAGE THE NEEDLE AND DETAILS DIFFERENT FROM THE OLD ONE. REVERSE CUTTING DIDN¿T SAME THE OLD ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446566 ↗
• MalfunctionAug 2, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE SURGEON COMPLAINT ABOUT THE VCP486H IN NEW PACKAGE THE NEEDLE AND DETAILS DIFFERENT FROM THE OLD ONE. REVERSE CUTTING DIDN¿T SAME THE OLD ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444699 ↗
• MalfunctionJan 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL CAVITY. DURING THE PROCEDURE, THE SUTURE BROKE EASILY WHEN SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161285 ↗
• MalfunctionJan 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL CAVITY. DURING THE PROCEDURE, THE SUTURE BROKE EASILY WHEN SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156920 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL CAVITY. FOLLOWING THE PROCEDURE, THE PATIENT SUFFERED A BURST ABDOMEN RESULTING IN A RETURN TO SURGERY FOR REPAIR OF THE ABDOMEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16156917 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL CAVITY. FOLLOWING THE PROCEDURE, THE PATIENT SUFFERED A BURST ABDOMEN RESULTING IN A RETURN TO SURGERY FOR REPAIR OF THE ABDOMEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16156916 ↗
• MalfunctionJan 11, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTUE WAS USED. DURING TYING, THE NEEDLE CAME LOOSE FROM THE SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139078 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE THE TIP OF THE NEEDLE BREAKS, THIS OCCURRED AFTER CHANGING FROM ONE SUTURE TO ANOTHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485574 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE TIP OF THE NEEDLE BREAKS, THIS OCCURRED AFTER CHANGING FROM ONE SUTURE TO ANOTHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485573 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE TIP OF THE NEEDLE BREAKS, THIS OCCURRED AFTER CHANGING FROM ONE SUTURE TO ANOTHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485572 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE TIP OF THE NEEDLE BREAKS, THIS OCCURRED AFTER CHANGING FROM ONE SUTURE TO ANOTHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485570 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE TIP OF THE NEEDLE BREAKS, THIS OCCURRED AFTER CHANGING FROM ONE SUTURE TO ANOTHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485568 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE TIP OF THE NEEDLE BREAKS, THIS OCCURRED AFTER CHANGING FROM ONE SUTURE TO ANOTHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485565 ↗

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