Coated VICRYL VCPB946HRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705031056725), received between Aug 31, 2020 and Aug 24, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Material Separation” (18 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. May 10, 2024Class IIOpen, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2145-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410531 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PACKAGE WAS EMPTY WHEN JUST OPEN THE PACKAGE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888181 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839068 ↗
• MalfunctionDec 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828028 ↗
• MalfunctionDec 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682168 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. ON THE MORNING, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE USE OF SUTURE DURING THE SURGERY, AFFECTING SURGICAL USE. REPLACED THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542050 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE INTRAOPERATIVE SUTURING PROCESS, THE SUTURE WAS BROKEN. REPLACED WITH A NEW ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542031 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE NEEDLE DID NOT FELL INTO THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211207 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW SUBCUTANEOUS TISSUE. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY AND THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW SKIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454335 ↗
• MalfunctionJun 3, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR FOUND PRESSURE MARKS ON THE OUTER PACKAGING BEFORE OPENING THE SUTURE . CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449366 ↗
• MalfunctionJun 3, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 8-MAY-2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR FOUND PRESSURE MARKS ON THE OUTER PACKAGING BEFORE OPENING THE SUTURE . CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449351 ↗
• MalfunctionFeb 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748207 ↗
• MalfunctionFeb 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C- SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF SUTURE THE NEEDLE HAPPENED WHEN SUTURING THE UTERINE WOUND. CHANGED TO 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 18699437 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UTERINE WOUND PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING UTERINE WOUND. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610761 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596916 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596914 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596912 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596849 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596836 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596830 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596828 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596826 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596825 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596821 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A WRONG NEEDLE PATTERN ON THE BOX. IT WAS REPORTED THAT THE NEEDLE PATTERN ON THE BOX SHOULD BE ETHIGUARD WHICH NEEDLE TIP SHOULD BE A LITTLE ROUNDED. BUT ACTUALLY THE NEEDLE TIP OF THE PATTERN IS POINTED AS ATTACHED PHOTO SHOWS. THIS ISSUE WAS FOUND DURING GOODS INSPECTION. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596489 ↗

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-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