Coated VICRYL VCP773DRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031055490), received between Jul 27, 2020 and Jul 30, 2025 — classified as 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Break; Material Discolored; Dull, Blunt; Break; Material Discolored; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. DURING USE, THE DOCTOR REPORTED THAT THE NEEDLE TIP WAS BLUNT. AFTER REMOVAL, IT WAS FOUND THAT THE NEEDLE TIP WAS BLACK AND MISSING A SECTION. AFTER REPEATED SEARCH AND TISSUE REMOVAL, INTRAOPERATIVE C-ARM FLUOROSCOPY AND COLOR ULTRASOUND DID NOT DETECT THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663505 ↗
• MalfunctionMay 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE 2D DATA MATRIX BARCODES COULD NOT BE SCANNED. IT'S REPORTED THAT 2D DATA MATRIX BARCODES ON THE PACKAGE COULD NOT BE SCANNED WHICH MAKE TROUBLE ON CUSTOMER'S WAREHOUSING WORK. AS THEY MANAGE PRODUCT ON PACKAGE LEVEL. AND THEY FEEDBACK THE TEXT ON THE PACKAGE IS NOT ENOUGH, THEY STILL WANT TO SCAN THE 2D DATA MATRIX BARCODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074262 ↗
• MalfunctionMay 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE 2D DATA MATRIX BARCODES COULD NOT BE SCANNED. IT'S REPORTED THAT 2D DATA MATRIX BARCODES ON THE PACKAGE COULD NOT BE SCANNED WHICH MAKE TROUBLE ON CUSTOMER'S WAREHOUSING WORK. AS THEY MANAGE PRODUCT ON PACKAGE LEVEL. AND THEY FEEDBACK THE TEXT ON THE PACKAGE IS NOT ENOUGH, THEY STILL WANT TO SCAN THE 2D DATA MATRIX BARCODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074214 ↗
• MalfunctionMar 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN CUSTOMER SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599317 ↗
• MalfunctionFeb 28, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED WITH HOLE PRIOR TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796556 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN FIXING THE INCISION WITH SUTURE, THE SUTURE BROKE AND COULD NOT BE FIXED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17809885 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CERVICAL LYMPHADENECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. AT 15:30, THE PATIENT UNDERWENT SURGERY. WHEN DOCTORS USE SUTURES TO SEW TISSUE, THE SUTURE BROKEN. REPLACE THE SUTURE AND TIE THE TISSUE. THE SURGERY WAS SUCCESSFULLY COMPLETED AT 17:40. NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357332 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CERVICAL LYMPHADENECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. AT 15:30, THE PATIENT UNDERWENT SURGERY. WHEN DOCTORS USE SUTURES TO SEW TISSUE, 2ND SUTURE WAS BROKEN. REPLACE THE SUTURE AND TIE THE TISSUE. THE SURGERY WAS SUCCESSFULLY COMPLETED AT 17:40. NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357319 ↗
• MalfunctionSep 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563460 ↗
• MalfunctionSep 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563458 ↗
• MalfunctionSep 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563449 ↗
• MalfunctionSep 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563431 ↗
• MalfunctionJul 27, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE WHEN SEWING. THE BROKEN NEEDLE WAS RETRIEVED IMMEDIATELY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325833 ↗

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