Coated VICRYL VCP260HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031051805), received between May 13, 2019 and Oct 30, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ON (B)(6) 2025 THAT A DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423872 ↗
• MalfunctionMar 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL REPAIR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURE BROKE INSIDE THE PATIENT AND WAS RETRIEVED BY THE DOCTOR. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598356 ↗
• MalfunctionJun 24, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY AND CYSTOSCOPY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058372 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE WHILE PUSHING THROUGH THE FASCIA. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT REPORTED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737201 ↗
• MalfunctionMay 13, 2019Break

  THE TIP OF THE SUTURE NEEDLE BROKE DURING TVH PROCEDURE AS FOLLOWS; ONCE THE POSTERIOR UTERUS WAS FREED FROM THE RECTUM THE PERITONEUM WAS THEN PICKED UP AND ENTERED SHARPLY WITH METZENBAUM SCISSORS. A DEAVER SKI SLOPE WEIGHTED SPECULUM WAS PLACED WITHIN THE PERITONEUM. AT THIS TIME WE VISUALIZED THE UTEROSACRAL LIGAMENTS. THESE WERE CLAMPED WITH A HEANEY CLAMP AND LIGATED WITH #0 VICRYL SUTURE. A HEANEY CLAMP AND VICRYL WAS THEN USED TO MATCH UP THE BILATERAL UTERINE PEDICLES IN AN ALTERNATING FASHION UNTIL THE UTERUS WAS FREED UP AND REMOVED. THE TUBES AND OVARIES WERE NOT VISUALIZED ON EITHER SIDE. WE THEN REMOVED THE WEIGHTED DUCKBILL SPECULUM AND USED A SPONGE STICK TO PUSH AWAY THE BOWEL AND VISUALIZE THE ENTIRE AREA. WE INSPECTED FOR HEMOSTASIS. THERE WAS SOME BLEEDING OF THE RIGHT DISTAL PEDICLE THAT WAS SECURED WITH A HEMOSTATIC STITCH. AT THIS TIME THE NEEDLE TIP WAS NOTED TO BE BROKEN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8603221 ↗

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