Coated VICRYL VCP335HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031052437), received between Jun 8, 2021 and Nov 26, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. A NEEDLE BROKE WHEN THE FASCIA WAS CLOSED. INTRAOPERATIVE FLUORO RX WAS PERFORMED WITH PZ STILL INTUBATED. THE NEEDLE FRAGMENT WAS FOUND AND REMOVED, WITHOUT ANY DAMAGE TO THE PC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658431 ↗
• MalfunctionMay 2, 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 BY THE SURGEON THAT AFTER THE SUTURE WAS USED THE SURGICAL TECH HAD PUT THE SUTURE IN THE NEEDLE HOLDER AND NOTICED THE TIP HAD BROKEN OFF AND WAS ALSO IN THE NEEDLE HOLDER. BOTH THE SUTURE AND THE NEEDLE TIP ARE BOTH IN THE MAGNETIC SUTURE HOLDER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950757 ↗
• MalfunctionSep 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE END OF THE LAPAROSCOPIC SURGERY, AT THE TIME OF BAND CLOSURE, THE NEEDLE BREAKS IN HALF, NEEDLE IN USE IN THE SUBCUTIS, IMMEDIATELY INTERCEPTED AND RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712438 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING UMBILICAL BAND CLOSURE, THERE WAS RUPTURE IN TWO PARTS OF THE SUTURE NEEDLE. CONTROL ABDOMEN RX PERFORMED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694186 ↗
• MalfunctionJun 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE INTO 2 PARTS. BOTH PARTS WERE RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959268 ↗

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