Coated VICRYL VCP589H (UDI 10705031054288)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031054288), received between May 11, 2021 and Mar 20, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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 18, 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.

• MalfunctionMar 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPRAY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP OF AN CANINE SPAY PROCEDURE THAT THE PATIENT HAD A SUTURE THAT DID NOT DISSOLVE WHICH CREATED A SMALL MASS THAT NEEDING TO BE CUT OUT MONTHS LATER. THE MASS CREATED A SMALL ABSCESS THAT WAS OOZING AND WOULD NOT RESPOND TO ANTIBIOTICS. PATIENT CURRENTLY DOING BETTER AND HAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Fluid Discharge

  MAUDE report 21652002 ↗
• MalfunctionDec 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE SNAPPED AT THE NEEDLE AND SUTURE INTERCHANGE. THE PROCEDURE WAS DELAYED BY ONE MINUTE. A REPLACEMENT SUTURE OF THE SAME CODE WAS ACQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911674 ↗
• MalfunctionDec 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE SNAPPED AT THE NEEDLE AND SUTURE INTERCHANGE. THE PROCEDURE WAS DELAYED BY ONE MINUTE. A REPLACEMENT SUTURE OF THE SAME CODE WAS ACQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911507 ↗
• MalfunctionDec 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE SNAPPED AT THE NEEDLE AND SUTURE INTERCHANGE. THE PROCEDURE WAS DELAYED BY ONE MINUTE. A REPLACEMENT SUTURE OF THE SAME CODE WAS ACQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15909705 ↗
• MalfunctionDec 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE SNAPPED AT THE NEEDLE AND SUTURE INTERCHANGE. THE PROCEDURE WAS DELAYED BY ONE MINUTE. A REPLACEMENT SUTURE OF THE SAME CODE WAS ACQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15909464 ↗
• MalfunctionDec 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE SNAPPED AT THE NEEDLE AND SUTURE INTERCHANGE. THE PROCEDURE WAS DELAYED BY ONE MINUTE. A REPLACEMENT SUTURE OF THE SAME CODE WAS ACQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15908570 ↗
• MalfunctionAug 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE NEEDLE. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199844 ↗
• MalfunctionAug 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE NEEDLE. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199843 ↗
• MalfunctionAug 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE NEEDLE. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199842 ↗
• MalfunctionJul 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT CLOSURE PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHILE USING THE SUTURE TO CLOSE THE FAT LAYER, THE SUTURE AND NEEDLE BECAME DISCONNECTED. IT WAS UNKNOWN IF THE SUTURE BROKE CLOSE TO THE NEEDLE OR THE NEEDLE FELL OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS DELAYED TEN MINUTES. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081314 ↗
• MalfunctionJul 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT CLOSURE PROCEDURE ON (B)(6)2022 AND THE SUTURE WAS USED. DURING SURGERY, WHILE USING THE SUTURE TO CLOSE THE FAT LAYER, THE SUTURE AND NEEDLE BECAME DISCONNECTED. IT WAS UNKNOWN IF THE SUTURE BROKE CLOSE TO THE NEEDLE OR THE NEEDLE FELL OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS DELAYED TEN MINUTES. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081312 ↗
• MalfunctionJul 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT CLOSURE PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHILE USING THE SUTURE TO CLOSE THE FAT LAYER, THE SUTURE AND NEEDLE BECAME DISCONNECTED. IT WAS UNKNOWN IF THE SUTURE BROKE CLOSE TO THE NEEDLE OR THE NEEDLE FELL OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS DELAYED TEN MINUTES. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081311 ↗
• MalfunctionJul 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT CLOSURE PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHILE USING THE SUTURE TO CLOSE THE FAT LAYER, THE SUTURE AND NEEDLE BECAME DISCONNECTED. IT WAS UNKNOWN IF THE SUTURE BROKE CLOSE TO THE NEEDLE OR THE NEEDLE FELL OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS DELAYED TEN MINUTES. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081310 ↗
• MalfunctionJul 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT CLOSURE PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHILE USING THE SUTURE TO CLOSE THE FAT LAYER, THE SUTURE AND NEEDLE BECAME DISCONNECTED. IT WAS UNKNOWN IF THE SUTURE BROKE CLOSE TO THE NEEDLE OR THE NEEDLE FELL OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS DELAYED TEN MINUTES. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081307 ↗
• MalfunctionJul 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT CLOSURE PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHILE USING THE SUTURE TO CLOSE THE FAT LAYER, THE SUTURE AND NEEDLE BECAME DISCONNECTED. IT WAS UNKNOWN IF THE SUTURE BROKE CLOSE TO THE NEEDLE OR THE NEEDLE FELL OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS DELAYED TEN MINUTES. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081306 ↗
• MalfunctionJul 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE WAS CHIPPED OFF AFTER THE SURGEON CLOSED THE WOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15024301 ↗
• MalfunctionMay 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE ¿BROKE AWAY¿ AT THE SUTURE CONNECTION DURING SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824870 ↗
• MalfunctionMay 13, 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 SUTURE BROKE AT THE SWAGE. 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 11821584 ↗
• MalfunctionMay 13, 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 SUTURE BROKE AT THE SWAGE. 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 11821449 ↗
• MalfunctionMay 12, 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 SUTURE BROKE AT THE SWAGE. 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 11815429 ↗
• MalfunctionMay 12, 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 SUTURE BROKE AT THE SWAGE. 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 11815258 ↗
• MalfunctionMay 11, 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 SUTURE BROKE AT THE SWAG. 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 11808967 ↗

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