Coated VICRYL VCP270HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031051935), received between Sep 11, 2024 and Aug 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS OPENED TO THE FIELD AND RN NOTICED THE TIP OF THE SUTURE WAS MISSING DIRECTLY FROM PACKAGE. THE NEEDLE WAS NOT USED ON PATIENT AND HANDED OFF IMMEDIATELY WITH PACKAGING. NO HARM TO PATIENT OR CLINICAL STAFF. THE DEFECTIVE ITEM WAS NOT SAVED AND CANNOT BE SENT FOR FURTHER ASSESSMENT. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885127 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO DL BY THE ACCOUNT CONTACT THAT THE DOCTOR REPORTED THAT THE SUTURE WAS THINNER THAN WHAT IT'S NORMALLY SUPPOSED TO BE LIKE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE RETURNING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562779 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THE NEEDLE DID NOT FALL INTO THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189269 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 16-AUG-2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THE NEEDLE DID NOT FALL INTO THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189256 ↗

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