Coated VICRYL VCP415HRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031052994), received between Nov 8, 2019 and Dec 31, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER GENERATOR CHANGEOUT ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN SUTURING THROUGH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935031 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT CONTACT THAT THE NEEDLE BROKE IN HALF WHEN SUTURING THROUGH SCAR TISSUE, IT WAS NOT RETAINED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905828 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT CONTACT THAT THE NEEDLE BROKE IN HALF WHEN SUTURING THROUGH SCAR TISSUE, IT WAS NOT RETAINED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905827 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT DAMAGED NEEDLE TIP WAS OBSERVED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE CUSTOMER HAD A TWO SUTURE ISSUE ONE BROKE AND THE OTHER WITH THE SAME LOT NUMBER DOESN'T HAVE TIP WHEN REMOVING ON THE PACKAGE. THIS HAPPEN WITH THE SAME CASE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705701 ↗
• MalfunctionSep 12, 2025Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING REPAIR OF VAGINAL LACERATION WHICH OCCURRED DURING VAGINAL BIRTH IN 2025, THE NEEDLE DISCONNECTED FROM SUTURE AT SWEDGE AND BECAME LOST IN-PATIENT TISSUE. THIS HAPPENED AGAIN ON A DIFFERENT SUTURE WITH SAME LOT NUMBER- THE NEEDLE ALSO BENT WITH THE SECOND SUTURE. IT WAS DIFFICULT TO RETRIEVE AND REMOVE NEEDLE. THE ACCOUNT SEQUESTERED ALL OF THESE SAME LOT NUMBERS. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042046 ↗
• MalfunctionSep 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING REPAIR OF VAGINAL LACERATION WHICH OCCURRED DURING VAGINAL BIRTH IN 2025, THE NEEDLE DISCONNECTED FROM SUTURE AT SWEDGE AND BECAME LOST IN-PATIENT TISSUE. THIS HAPPENED AGAIN ON A DIFFERENT SUTURE WITH SAME LOT NUMBER- THE NEEDLE ALSO BENT WITH THE SECOND SUTURE. IT WAS DIFFICULT TO RETRIEVE AND REMOVE NEEDLE. THE ACCOUNT SEQUESTERED ALL OF THESE SAME LOT NUMBERS. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042036 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT DURING TWO UNKNOWN PROCEDURES THAT WHILE SUTURING THE SUBCUTANEOUS LAYER OF TISSUE THE NEEDLE BROKE OFF. UNKNOWN IF THE BROKEN FRAGMENT WAS RETRIEVED FROM EITHER PATIENT. . NO PRODUCT RETURNING.. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925809 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT DURING TWO UNKNOWN PROCEDURES THAT WHILE SUTURING THE SUBCUTANEOUS LAYER OF TISSUE THE NEEDLE BROKE OFF. UNKNOWN IF THE BROKEN FRAGMENT WAS RETRIEVED FROM EITHER PATIENT. NO PRODUCT RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925808 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM #MW (B)(4), DURING SUTURE PROCEDURE, THE NEEDLE BROKE IN HALF WHILE SUTURING. ABLE TO FIND BOTH HALVES OF NEEDLE. UNKNOWN IF THE DEVICE WAS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524510 ↗
• MalfunctionNov 8, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING A SEWING WOUND SURGERY. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297204 ↗

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