Coated VICRYL VCPB947HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031056749), received between Sep 17, 2018 and Mar 13, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE BROKE DURING USE AND THIS HAPPENED TWICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897472 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE BROKE DURING USE AND THIS HAPPENED TWICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897470 ↗
• MalfunctionSep 15, 2023Material Integrity Problem; Material Integrity Problem

  TI WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE WAS DETACHED FROM THE NEEDLE ALREADY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756121 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792159 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON 02/04/2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE AFTER PUTTING THE 1ST STITCH ON THE MYOMETRIUM, THE NEEDLE CAME OFF, SO THE SURGEON THOUGHT THAT THE NEEDLE WAS DETACHED FROM THE SUTURE, BUT IT WAS FOUND THAT THE NEEDLE WAS BROKEN AT 2 ¿ 3MM POINT FROM THE EDGE OF THE SWAGE PART. NO PIECES FELL INTO THE PATIENT. THE BROKEN PART WAS NOT GRASPED BY THE NEEDLE HOLDER, AND NO EXTRA FORCE WAS APPLIED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396829 ↗
• MalfunctionAug 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370249 ↗
• MalfunctionApr 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9930214 ↗
• MalfunctionMar 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. WHILE USING A NEEDLE-SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON THE MYOMETRIUM. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9783096 ↗
• MalfunctionSep 17, 2018Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE PACKAGES OF THEM WERE NOT FOR THE PRODUCT EXPECTED, BUT FOR A DIFFERENT PRODUCT IN THE BOX. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881324 ↗

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