Coated VICRYL VCP392ZHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031078086), received between Oct 18, 2023 and Mar 19, 2024 — classified as 3 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934659 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SUSPECTED INFECTION. THE PATIENT WAS ADMITTED FOR IN-PATIENT MANAGEMENT FOR AN INFECTION AT THE CAUDAL PART OF THE SEPTUM. THE PATIENT BECAME INFECTION FREE AFTER READMISSION AND STARTING IV ANTIBIOTICS. THE SURGEON CHECKED THE YELLOW LABEL ON THE PRODUCT WITH THE IRANIAN MINISTRY OF HEALTH WEBSITE AND THIS PRODUCT WAS REGISTERED ON THE GOVERNMENT WEBSITE, BUT THE SURGEON'S MOBILE PHONE COULD NOT RECOGNIZE THE QR CODE AND BARCODE ON THE BOX PRINTED BY THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 18231132 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED A SUSPECTED INFECTION. THE SURGEON CHECKED THE YELLOW LABEL ON THE PRODUCT WITH THE IRANIAN MINISTRY OF HEALTH WEBSITE AND THIS PRODUCT WAS REGISTERED ON THE GOVERNMENT WEBSITE, BUT THE SURGEON'S MOBILE PHONE COULD NOT RECOGNIZE THE QR CODE AND BARCODE ON THE BOX PRINTED BY THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 17958006 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED A SUSPECTED INFECTION. THE SURGEON CHECKED THE YELLOW LABEL ON THE PRODUCT WITH THE IRANIAN MINISTRY OF HEALTH WEBSITE AND THIS PRODUCT WAS REGISTERED ON THE GOVERNMENT WEBSITE, BUT THE SURGEON'S MOBILE PHONE COULD NOT RECOGNIZE THE QR CODE AND BARCODE ON THE BOX PRINTED BY THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17957526 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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