Coated VICRYL VCPB841DRecalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10705031056640), received between Dec 27, 2017 and Aug 21, 2026 — classified as 2 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Material Separation” (94 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 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50373404 ↗
• MalfunctionAug 21, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50373402 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE AND THE SUTURE HAD BEEN DETACHED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. UPON VISUAL INSPECTION OF DETACHED NEEDLES, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE BARREL HOLE OF THE NEEDLES WAS EXAMINED UNDER MAGNIFICATION WITH NO SUTURE REMNANT NOTED. HOWEVER, A SHORT INSERTION WAS OBSERVED IN THE END OF THE DISPENSED SUTURE, AS THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. THE OTHERS FOUR SUTURES WERE NOT RETURNED FOR EVALUATION. IN THE INSPECTIONS OF THREE NEEDLE SUTURE COMBINATIONS THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. AS THE SUTURES ARE ABSORBABLE AND THE DURATION OF EXPOSURE OF THE SUTURE IN THE ENVIRONMENT COULD NOT BE DETERMINED, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SHORT INSERTION ISSUE WAS IDENTIFIED AS WRONG NUMBER OF STRANDS DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431569 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN OPEN ORTHOPEDIC SURGERY, WHEN PASSING THE NEEDLE THROUGH THE TISSUE AND PULLING THE NEEDLE OUT FROM THE TISSUE, THE SUTURE ALSO DETACHED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905698 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, WHEN THE DOCTOR REPOSITIONED THE NEEDLE AND TRIED TO PULL IT OUT DURING SKIN SUTURING, THE SUTURE DETACHED EASILY, AND SUTURING COULD NOT BE DONE. IT WAS 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 23878668 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872125 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872121 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872108 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872105 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871997 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871990 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871978 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871975 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871844 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871824 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871816 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE-SUTURE WAS DETACHED. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871809 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS EASY TO DETACH DURING USE THE PRODUCT. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817933 ↗
• MalfunctionDec 12, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, ORIGINALLY THE SHAPE OF VCPB841D SUTURE SHOULD HAVE BEEN 1/2 CIRCLE, BUT SOME OF THE NEEDLES WERE 3/8 CIRCLE. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791486 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE NEEDLE AND SUTURE DETACHED EASILY WHILE USING. THE PROCEDURE DATE AND THE MEDICAL DEPARTMENT WHERE THE PRODUCT WAS USED ARE CURRENTLY UNKNOWN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646940 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE NEEDLE AND SUTURE DETACHED EASILY WHILE USING. THE PROCEDURE DATE AND THE MEDICAL DEPARTMENT WHERE THE PRODUCT WAS USED ARE CURRENTLY UNKNOWN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646885 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE NEEDLE AND SUTURE DETACHED EASILY WHILE USING. THE PROCEDURE DATE AND THE MEDICAL DEPARTMENT WHERE THE PRODUCT WAS USED ARE CURRENTLY UNKNOWN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646882 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE NEEDLE AND SUTURE DETACHED EASILY WHILE USING. THE PROCEDURE DATE AND THE MEDICAL DEPARTMENT WHERE THE PRODUCT WAS USED ARE CURRENTLY UNKNOWN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646868 ↗
• MalfunctionOct 27, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT AFTER OPENING THE PACKAGE, IT WAS JUDGED BEFORE USE THAT THE SUTURE WAS UNUSABLE DUE TO THE BLACK COLOR (STAIN) ON THE SURFACE OF THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393780 ↗
• MalfunctionOct 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED WHEN REMOVED IT OR IN AN UNINTENDED SCENE. THE DOCTOR FEELS THAT THE JOINT WAS WEAK. OTHER DEFECTIVE PRODUCTS WERE DISCARDED. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381106 ↗

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