Coated VICRYL VCP434HRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10705031053212), received between Jun 21, 2019 and May 19, 2026 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Material Separation” (49 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE AND THE NEEDLE WAS DETACHED WHILE SUTURING FOR TWO TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221567 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE AND THE NEEDLE WAS DETACHED WHILE SUTURING FOR TWO TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221566 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, ALTHOUGH THIS PRODUCT IS NOT A CONTROL RELEASE, THE SUTURE AND THE NEEDLE DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921144 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHILE STITCHING THE TISSUE. PART OF THE SUTURE WERE LEFT IN THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957499 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOLE EXCISION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 3:00 PM, DURING THE SURGICAL PROCEDURE, THE SUTURE BROKE MULTIPLE TIMES DURING SUTURING. DISCONTINUED USE, CHANGE BATCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928061 ↗
• MalfunctionOct 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS COMING OFF FROM THE SUTURE, AND THE TEAM WENT THROUGH SEVERAL PACKS. REPLACEMENT NEEDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343476 ↗
• MalfunctionSep 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS COMING OFF FROM THE SUTURE, AND THE TEAM WENT THROUGH SEVERAL PACKS. REPLACEMENT NEEDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176331 ↗
• MalfunctionJul 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. MOST OF THE SUTURES WERE COME OFF FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS STOPPED TO USE OF THE PRODUCT IN THE SAME BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701929 ↗
• MalfunctionJul 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. MOST OF THE SUTURES WERE COME OFF FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS STOPPED TO USE OF THE PRODUCT IN THE SAME BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701902 ↗
• MalfunctionJun 19, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PART NUMBER LOOKS CORRECT BUT THE SUTURE IS INCORRECT, THE NEEDLE SHOWS TF AND IT IS SUPPOSED TO BE RB-2. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19569673 ↗
• MalfunctionJun 10, 2024Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS FRAYED & POPPING OFF THE NEEDLE. THEY USED A DIFFERENT LOT OF SUTURE TO COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505636 ↗
• MalfunctionJun 10, 2024Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS FRAYED & POPPING OFF THE NEEDLE. THEY USED A DIFFERENT LOT OF SUTURE TO COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505501 ↗
• MalfunctionJun 10, 2024Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS FRAYED & POPPING OFF THE NEEDLE. THEY USED A DIFFERENT LOT OF SUTURE TO COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505499 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312369 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312365 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312360 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312358 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312351 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312337 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312336 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VEAU 3 CLEFT PALATE REPAIR WITH BILATERAL PEDICLE BUCCAL FAT FLAPS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312334 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. AT 16:00, THE DOCTOR USED ONE SUTURE TO SEW WOUND ON A PATIENT WITH A HAND INJURY. AFTER A FEW STITCHES, THE NEEDLE BROKE. IMMEDIATELY REPORTED TO THE HEAD NURSE AND EQUIPMENT DEPARTMENT. THIS SUTURE WAS IMMEDIATELY DISCONTINUED AND THE BROKEN NEEDLE WAS IMMEDIATELY SEARCHED FOR. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087676 ↗
• MalfunctionFeb 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS NOT 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 18705732 ↗
• MalfunctionFeb 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS NOT 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 18705650 ↗
• MalfunctionFeb 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS NOT 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 18705646 ↗

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