Coated VICRYL VCP864DRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10705031055872), received between Jun 12, 2019 and Sep 29, 2026 — classified as 30 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  It was reported that a patient underwent a small bowel procedure on an unknown date and suture was used. During surgery, the tip of the needle driver was observed to be missing when the needle was returned. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935564 ↗
• MalfunctionSep 29, 2026Break

  It was reported that a patient underwent a small bowel procedure on an unknown date and suture was used. During surgery, the tip of the needle driver was observed to be missing when the needle was returned. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935473 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452504 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452503 ↗
• MalfunctionJul 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747003 ↗
• MalfunctionMar 2, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING SURGERY PREPARATION, A BLACK SPECK/BLACK SUBSTANCE WAS OBSERVED INSIDE THE STERILE PACKAGING OF THE DEVICE. THE PRESENCE OF THIS FOREIGN MATERIAL INDICATES A POTENTIAL STERILITY COMPROMISE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488080 ↗
• MalfunctionMar 2, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING SURGERY PREPARATION, A BLACK SPECK/BLACK SUBSTANCE WAS OBSERVED INSIDE THE STERILE PACKAGING OF THE DEVICE. THE PRESENCE OF THIS FOREIGN MATERIAL INDICATES A POTENTIAL STERILITY COMPROMISE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487288 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY THE SURGEON WAS HAVING TROUBLE WITH THE SUTURE. THE SUTURE WAS SPITTING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555218 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY THE SURGEON WAS HAVING TROUBLE WITH THE SUTURE. THE SUTURE WAS SPITTING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555145 ↗
• MalfunctionJun 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A TINY HAIR IN IT WHEN IT WAS OPENED. ONE DEVICE WILL BE RETURNED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177311 ↗
• InjuryMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS BROUGHT BACK TO THE OR WITH WOUND DEHISCENCE OF THE ENTIRE WOUND CLOSURE. WOUND WAS IRRIGATED THEN RECLOSED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22031151 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TLIF L5-S1 PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A EFT POSTERIOR INCISION DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22012270 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL L4,L5 LAMINECTOMY WITH LEFT L5-S1 MCD ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INCISION DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22012256 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A L1 LAMINECTOMY WITH L1-2 MCD ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INCISION DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22012255 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880642 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880640 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880638 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880637 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880634 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880633 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880632 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880630 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880628 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND DEHISCED RIGHT AT THE APEX OF THE INCISION CLOSE TO THE MIDPOINT. A DIME SIZE HOLE THAT WAS STARTING TO CLOSE BUT IS AN OPEN IN THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21880627 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, "FALLING OFF NEEDLES". CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859455 ↗

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