Coated VICRYL VCPB724DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031056497), received between Aug 15, 2022 and Jun 14, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CERVICAL SPINAL CANAL ENLARGEMENT FOR CERVICAL SPONDYLOTIC MYELOPATHY ON (B)(6) 2024 AND SUTURE WAS USED. A WEEK AFTER THE PROCEDURE, REDNESS INFLAMMATION HAD OCCURRED. EXUDATE DID NOT STOP FLOWING OUT. THE DOCTOR OPENED THE WOUND 2 WEEKS AFTER THE PROCEDURE AND CONFIRMED INSIDE THE WOUND. THE INFLAMMATION WAS NOT CONFIRMED ON FASCIA, BUT INFLAMMATION WAS CONFIRMED ON SUBCUTANEOUS. SINCE THE JELLY-LIKE SUBSTANCE WAS PRESENT UNDER THE SKIN, THE DOCTOR THOUGHT THAT THE JELLY-LIKE SUBSTANCE WAS A DISSOLVED SUTURE. THE INFLAMMATION OCCURRED ON THE EDGE, AND THE DOCTOR REMOVED THE SUTURE, WHICH HAD BEEN USED ON THE INFLAMMATION PART OF THE SUBCUTANEOUS. THE INFLAMMATION WAS REDUCED ON SUTURE REMOVED PART, BUT THE INFLAMMATION ON OTHER PART WAS CONTINUED, AND HYPERTROPHIC SCAR OCCURRED. THE DOCTOR THOUGHT THAT THE PRODUCT IS RESPONSIBLE FOR THE APPEARANCE OF SYMPTOMS BECAUSE HYPERTROPHIC SCAR HAS APPEARED IN THE AREA WHERE THE PRODUCTS WERE LOCATED UNDER THE SKIN. THE DOCTOR DID NOT THINK IT'S SSI: SURGICAL SITE INFECTION. AFTER THAT, EXUDATE FLOWING OUT STOPPED. THE STEROIDS WERE APPLIED TO REDUCE INFLAMMATION. THE DOCTOR THINKS IT?S CONTACT DERMATI

  Patient problems: Fluid Discharge; Inflammation; Pocket Erosion; Scar Tissue; Skin Inflammation/ Irritation

  MAUDE report 19538920 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  +IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532602 ↗
• MalfunctionAug 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, BETWEEN THE NEEDLE AND SUTURE, KEPT EASILY BREAKING OFF SEVERAL TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229837 ↗

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