Coated VICRYL VCP329HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031052352), received between Aug 14, 2025 and Mar 3, 2026 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE TIP OF NEEDLE BROKE OFF WHILE CLOSING FASCIA. X-RAY WAS USED TO FIND TIP AND NEEDLE. NO PATIENT INJURY. THIS DID PROLONG THE SURGERY TIME DUE TO LOOKING FOR THE NEEDLE TIP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24500299 ↗
• InjuryFeb 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC CHOLECYSTECTOMY ON (B)(6) 2026 AND SUTURE WAS USED TO CLOSE FASCIA. THE SURGEON TOOK 1 PASS THROUGH THE TISSUE SUCCESSFULLY AND THEN 2ND PASS THROUGH, THE TIP OF THE NEEDLE BROKE OFF AND BECAME LODGED IN TISSUE AND UNABLE TO VISUALIZE. CALLED RADIOLOGY TO PERFORM X-RAY TO CONFIRM LOCATION OF NEEDLE PIECE. SURGEON WENT AHEAD AND FINISHED CLOSING SO SUTURE WOULD NOT FALL INTO ABDOMINAL SPACE. XRAY PERFORMED AND AFTER SEVERAL ATTEMPTS, THE NEEDLE WAS FOUND IN SUBCUTANEOUS TISSUE AND REMOVED BY THE SURGEON. CONFIRMED NEEDLE FULLY INTACT BY COMPARING TO ANOTHER SUTURE NEEDLE OF THE SAME SIZE. PROCEDURE COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24406133 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, TWO SUTURING NEEDLES BROKE WHILE PASSING THROUGH THE PATIENT'S SKIN. PATIENT'S ADVERSE EVENT WAS NOT DETERMINED. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808591 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, TWO SUTURING NEEDLES BROKE WHILE PASSING THROUGH THE PATIENT'S SKIN. PATIENT'S ADVERSE EVENT WAS NOT DETERMINED. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808550 ↗

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