Coated VICRYL VCP474HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031053557), received between Jun 16, 2020 and Oct 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2021Break; Break

  IT WAS REPORTED THAT A FEMALE DOG UNDERWENT AN OVARIECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, 5 DAYS AFTER THE PROCEDURE, THE X-STITCHES HAD BROKEN. NO ADDITIONAL WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665647 ↗
• MalfunctionJun 16, 2020Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY ON (B)(6) 2020 AND A SUTURE WAS USED. THE SURGEON NOTICED THAT THE NEEDLE TIP HAD BEEN MISSING DURING SUBCUTANEOUS SUTURING BY CONTINUOUS SUTURING. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE SURGEON SEARCHED FOR THE NEEDLE FRAGMENT BY X-RAY, BUT COULD NOT LOCATE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON COMMENTED: IT MAY HAVE BROKEN BECAUSE A SURGEON IN THE 4TH YEAR OF SURGERY GRASPED THE NEEDLE TIP STRONGLY WITH NEEDLE FORCEPS DURING SUTURING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10160417 ↗

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