Coated VICRYL VCP370H (UDI 10705031052833)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031052833), received between Jan 25, 2021 and Jan 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON SAW THE TIP OF THE NEEDLE IN THE FASCIA. THE SURGEON GOT THE TIP OUT. NEW SUTURE WAS PULLED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503240 ↗
• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE DOING THE FINAL SUTURE COUNT PRIOR TO CLOSURE IT WAS FOUND THAT THE TIP OF ONE OF THE NEEDLES WAS MISSING. FRAGMENT WAS UNABLE TO BE LOCATED AT FIRST, SO AN X-RAY WAS BROUGHT IN WHICH DID NOT SHOW THE NEEDLE IN THE PATIENT. THE TIP WAS LATER FOUND IN A DRAINAGE BAG BY USING AN EXTRA-LARGE MAGNET. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMAITON WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438989 ↗
• MalfunctionJun 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THREAD BROKE IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144977 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT 2/3 OF THE NEEDLE WHEN CLOSING THE UTERUS.. THE BROKEN ITEM WAS FOUND AND REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16779182 ↗
• 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15151723 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE KNOT TYING OF THE STITCH IN THE APEX OF THE WOUND WHERE IT BROKE ON THE FIRST KNOT MULTIPLE TIMES. THE SUTURE BROKE WHILE TYING THE KNOT. ANOTHER THICKER SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228078 ↗

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