Coated VICRYL VCP376HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031052895), received between Sep 20, 2019 and Feb 18, 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 18, 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.

• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE WAS BROKEN EASILY. IT WAS CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377905 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF. THE BROKEN FRAGMENT WAS RECOVERED. AN X-RAY WAS DONE TO FIND THE FRAGMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100799 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TRANS INGUINAL HERNIA PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF FROM THE ROOT (JUNCTION) DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505419 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHRECTOMY SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, MW5099954, "SURGEON WAS USING THE SUTURE WHEN PART OF THE NEEDLE BROKE AT APPROXIMATELY 1400 IN OPERATING ROOM 10. SURGEON WAS AWARE THAT PART OF THE NEEDLE REMAINED INSIDE OF THE PATIENT. SURGEON ATTEMPTED TO RETRIEVE ITEM, BUT ITEM WAS NOT FOUND. SURGEON DETERMINED IT WOULD BE MORE TRAUMATIC TO THE PATIENT TO DISSECT TISSUE TO REMOVE THE NEEDLE. AT CLOSING OF PROCEDURE, ANOTHER ATTEMPT WAS MADE TO LOCATE ITEM. ITEM WAS STILL NOT FOUND. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11737916 ↗
• MalfunctionMay 26, 2020Break; Break

  IT WAS REPORTED THAT A LAPAROSCOPIC PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING FASCIA CLOSING, THE SUTURE NEEDLE BROKE. THE BROKEN NEEDLE WAS RETRIEVED FROM THE PATIENT. X-RAY SHOWED NO RETAINED METALLIC FOREIGN BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086740 ↗
• MalfunctionApr 23, 2020Break

  DURING LAPAROSCOPIC PROCEDURE A FASCIA CLOSING SUTURE NEEDLE BROKE. THE BROKEN NEEDLE WAS RETRIEVED FROM THE PATIENT. X-RAY SHOWED NO RETAINED METALLIC FOREIGN BODY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9995140 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON 12/03/2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AND THE TIP WAS INSIDE THE PATIENT. AN X -RAY REVEALED THE LOCATION OF THE PIECE AND IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530502 ↗
• MalfunctionSep 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE SUTURE WAS BEHAVING LIKE A DE-TACH SUTURE, MEANING THE SUTURE WAS COMING AWAY FROM THE SWAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9100709 ↗

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