Coated VICRYL D10084Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031203198), received between May 17, 2019 and Jan 15, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LEFT EMPYEMA DECORTICATION ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, THE SUTURE DETACHED EASILY FROM THE NEEDLE SWAGE. 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 24087015 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LEFT EMPYEMA DECORTICATION ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, THE SUTURE DETACHED EASILY FROM THE NEEDLE SWAGE. 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 24087014 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LEFT EMPYEMA DECORTICATION ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, THE SUTURE DETACHED EASILY FROM THE NEEDLE SWAGE. 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 24087013 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LEFT EMPYEMA DECORTICATION ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, THE SUTURE DETACHED EASILY FROM THE NEEDLE SWAGE. 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 24087012 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LEFT EMPYEMA DECORTICATION ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, THE SUTURE DETACHED EASILY FROM THE NEEDLE SWAGE. 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 24087010 ↗
• MalfunctionDec 19, 2025Device Contaminated During Manufacture or Shipping; Material Integrity Problem; Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, BEFORE USING THE PRODUCT, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER TO THE NEEDLE TIP WHICH WAS AT THE POSITION MARKED ¿8¿. THE NEEDLE TIP ALSO SEEMS DULLER THAN USUAL. THE PRODUCT WAS IN THE SOT TRAY. 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 23851523 ↗
• MalfunctionMar 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN OPEN PANCREATICODUODENECTOMY (PD), IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER IN THE STERILIZATION PACKAGE. IT WAS A CONTROL RELEASE NEEDLE. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664359 ↗
• MalfunctionDec 12, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A FOREIGN MATTER WAS FOUND ON THE NEEDLE TIP. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919623 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN USING THE PRODUCT TO NEEDLE THE TISSUE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE METHOD WAS INTERRUPTED SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743760 ↗
• MalfunctionMar 8, 2022Material 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 SUTURE WAS DETACHED FROM THE NEEDLE EASIER THAN NORMAL ONES DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690876 ↗
• MalfunctionAug 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE FASCIA, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371775 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. WHEN TAKING OUT THE SUTURE FROM THE PACKAGE, IT WAS BROKEN SHORTLY. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9748410 ↗
• MalfunctionMay 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAMINECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING ON THE FASCIA. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621388 ↗
• MalfunctionMay 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAMINECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING ON THE FASCIA. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621386 ↗

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