Coated VICRYL VCP334HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031052413), received between Apr 18, 2023 and Jan 7, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SUTURE WAS TRIED TO TIE DURING USE, THE SUTURE BROKE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995054 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AND NO SIGNIFICANT DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979373 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AND NO SIGNIFICANT DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979351 ↗
• MalfunctionMar 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING ROBOTIC HYSTERECTOMY, THE SURGICAL TECH WAS PUTTING A SUTURE DOWN A TROCAR AND WHEN THE SUTURE WENT DOWN THE NEEDLE WENT MISSING. IT WAS HARD TO FIND THE NEEDLE. INTERVENTION WAS USED WITH X-RAY, OUTSIDE THE PATIENT. NEAR THE HIP. CASE WAS COMPLETED WITH A DIFFERENT SUTURE STILL AN ETHICON PRODUCT. NO PATIENT HARM WAS REPORTED. DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644498 ↗
• MalfunctionMar 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING ROBOTIC HYSTERECTOMY, THE SURGICAL TECH WAS PUTTING A SUTURE DOWN A TROCAR AND WHEN THE SUTURE WENT DOWN THE NEEDLE WENT MISSING. IT WAS HARD TO FIND THE NEEDLE. INTERVENTION WAS USED WITH X-RAY, OUTSIDE THE PATIENT. NEAR THE HIP. CASE WAS COMPLETED WITH A DIFFERENT SUTURE STILL AN ETHICON PRODUCT. NO PATIENT HARM WAS REPORTED. DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643746 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP APPENDECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE SUTURE BROKE OFF IN THE SKIN WHEN THE SURGEON WAS SUTURING CLOSED. THE SURGEON REMOVED THE PIECE OF THE BROKEN SUTURE FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18656057 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP APPENDECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS CLOSING THE FASCIA WHEN THE DISTAL 1/3RD OF THE SUTURE BROKE OFF. THE PROCEDURE WAS DELAYED. THE PIECE OF THE BROKEN SUTURE WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18656056 ↗
• MalfunctionApr 18, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ORTHOPEDIC PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE TIP SNAPPED OFF INTO A PATIENT. FURTHER IMAGING AND INVESTIGATION IS NEEDED TO FIND THE TIP. THERE IS NO REPORTED HARM TO THE PATIENT, HOWEVER, THE NEEDLE TIP DOES REMAIN IN-SITU INSIDE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16763821 ↗

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