Coated VICRYL VCP427HRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031053151), received between Mar 28, 2019 and Aug 19, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328942 ↗
• MalfunctionMar 18, 2026Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, THAT A FULL BOX OF SUTURES LABELED AND EXPECTED TO BE UNDYED WAS RECEIVED IN DYED FORM. THE DISCREPANCY WAS IDENTIFIED UPON INSPECTION OF THE PRODUCT, INDICATING A MISMATCH BETWEEN THE EXPECTED PRODUCT SPECIFICATIONS AND THE ITEMS DELIVERED. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626676 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. NEEDLE PULL OFF OCCURRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23852007 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE TIP IS BREAKING OFF. THIS HAS HAPPENED SEVERAL TIMES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713512 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE TIP IS BREAKING OFF. THIS HAS HAPPENED SEVERAL TIMES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713473 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE TIP IS BREAKING OFF. THIS HAS HAPPENED SEVERAL TIMES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713458 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE TIP IS BREAKING OFF. THIS HAS HAPPENED SEVERAL TIMES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713446 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE TIP IS BREAKING OFF. THIS HAS HAPPENED SEVERAL TIMES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713421 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE TIP IS BREAKING OFF. THIS HAS HAPPENED SEVERAL TIMES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713411 ↗
• MalfunctionNov 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE CLOSING THE SKIN LAYER ON THE KNEE, THE SURGEON ENCOUNTERED AN ISSUE WHEN, AFTER TYING THE THIRD KNOT, THE NEEDLE DETACHED FROM THE SUTURE. THIS REQUIRED HIM TO OPEN ANOTHER SUTURE TO COMPLETE THE CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599382 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE USER ARMED AND USED NEEDLE-SUTURE AS PROPERLY INDICATED, HOWEVER WHEN PERFORMING AN INSTRUMENT TIE, THE SUTURE CONTINUOUSLY KEPT BREAKING KNOT AFTER KNOT. THE USER ONLY EXPERIENCED THIS IN 1 X PCS, WHEN THEY OPENED A NEW ONE AND IT PERFORMED AS NORMAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820140 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE EASILY DURING PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13528814 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062158 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE IN THE TISSUE. AN X-RAY WAS ORDERED, AND THE NEEDLE WAS SUCCESSFULLY IDENTIFIED AND REMOVED FROM THE TISSUE. 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 12649233 ↗
• MalfunctionJan 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS NOT DISSOLVING AS SUPPOSED TO. THIS WAS CAUSING INFECTION AT THE SUTURE SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11105320 ↗
• MalfunctionJan 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS NOT DISSOLVING AS SUPPOSED TO. THIS WAS CAUSING INFECTION AT THE SUTURE SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11105319 ↗
• MalfunctionJan 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS NOT DISSOLVING AS SUPPOSED TO. THIS WAS CAUSING INFECTION AT THE SUTURE SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11105318 ↗
• MalfunctionDec 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9467371 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED FOR SKIN CLOSURE. DURING THE PROCEDURE, THE CUTTING NEEDLE WAS FOUND TO BE CHIPPED OFF AFTER A FEW STITCHES WERE DONE BY THE SURGEON. THE SUTURE WAS INTACT DURING THE INITIAL COUNT AND UPON HANDLING TO SURGEON FOR USE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735646 ↗
• MalfunctionMar 29, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL TENDON TRANSFER PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE DETACHED DURING SUTURING. THE PROCEDURE WAS COMPLETED WITH THIS SAME SUTURE MATERIAL USING MUCH SLOWER PASS THROUGH AND PULLING OF SUTURE. IT TOOK LONGER TO CLOSE INCISION DUE TO EXTRA PRECAUTION USED TO KEEP NEEDLE FROM DETACHING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464346 ↗
• MalfunctionMar 29, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL TENDON TRANSFER PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE DETACHED DURING SUTURING. THE PROCEDURE WAS COMPLETED WITH THIS SAME SUTURE MATERIAL USING MUCH SLOWER PASS THROUGH AND PULLING OF SUTURE. IT TOOK LONGER TO CLOSE INCISION DUE TO EXTRA PRECAUTION USED TO KEEP NEEDLE FROM DETACHING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464187 ↗
• MalfunctionMar 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL TENDON TRANSFER PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE DETACHED DURING SUTURING. THE PROCEDURE WAS COMPLETED WITH THIS SAME SUTURE MATERIAL USING MUCH SLOWER PASS THROUGH AND PULLING OF SUTURE. IT TOOK LONGER TO CLOSE INCISION DUE TO EXTRA PRECAUTION USED TO KEEP NEEDLE FROM DETACHING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462881 ↗

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