Coated VICRYL J489GRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031040427), received between Jun 12, 2019 and Feb 21, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY PLASTIC SURGEON THAT THE SUTURE DETACHED FROM THE NEEDLE'S SWAGED END ON THE FIRST ATTEMPT WHILE SUTURING THE DERMIS. UPON OPENING A NEW PACKET, THE VICRYL 6/0 SUTURE FRAYED AND BROKE DURING USE FOR THE SECOND TIME. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW SUTURE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438659 ↗
• MalfunctionFeb 21, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY PLASTIC SURGEON THAT THE SUTURE DETACHED FROM THE NEEDLE'S SWAGED END ON THE FIRST ATTEMPT WHILE SUTURING THE DERMIS. UPON OPENING A NEW PACKET, THE VICRYL 6/0 SUTURE FRAYED AND BROKE DURING USE FOR THE SECOND TIME. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW SUTURE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437789 ↗
• MalfunctionJan 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE EXTERIOR BOX SHOWS EXPIRATION OF 03/31/2029. SUTURE PACKETS STAMPED WITH 05/15/2024 EXP DATE. BOX OPENED, TWO SWAGS USED BEFORE CLINIC NOTICED THE DISCREPANCY, TEN REMAINING. THERE WERE NO PATIENT CONSEQUENCE WAS REPORTED. DEVICE WILL BE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067478 ↗
• MalfunctionJan 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE EXTERIOR BOX SHOWS EXPIRATION OF 03/31/2029. SUTURE PACKETS STAMPED WITH 05/15/2024 EXP DATE. BOX OPENED, TWO SWAGS USED BEFORE CLINIC NOTICED THE DISCREPANCY, TEN REMAINING. THERE WERE NO PATIENT CONSEQUENCE WAS REPORTED. DEVICE WILL BE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067460 ↗
• MalfunctionNov 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE NEEDLE IS DISLODGED. SUTURE DISLODGED FROM THE SUTURE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636382 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COSMETIC SURGERY ON (B)(6) 2021, AND SUTURE WAS USED. DURING THE SURGERY, DURING INTERRUPTED SUTURING ON THE DERMIS, SUTURE BREAKAGE OCCURRED WITH 4 SUTURES IN A ROW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608115 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COSMETIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, DURING INTERRUPTED SUTURING ON THE DERMIS, SUTURE BREAKAGE OCCURRED WITH 4 SUTURES IN A ROW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608114 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COSMETIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, DURING INTERRUPTED SUTURING ON THE DERMIS, SUTURE BREAKAGE OCCURRED WITH 4 SUTURES IN A ROW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608112 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COSMETIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, DURING INTERRUPTED SUTURING ON THE DERMIS, SUTURE BREAKAGE OCCURRED WITH 4 SUTURES IN A ROW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608111 ↗
• MalfunctionSep 15, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SURGEON PASSED THE SUTURE THROUGH THE SKIN AND DUE TO HOW ROUGH THE SUTURE PASSED AND NOT PULLING THROUGH AS EASILY AS USUAL, THE SURGEON LOOKED CLOSER AND NOTICED IT CAME OUT FRAYED ON THE OTHER SIDE. THE SURGEON OPENED A SUTURE FROM A BOX WITH DIFFERENT LOT AND IT WORKED FINE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535069 ↗
• MalfunctionSep 15, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SURGEON PASSED THE SUTURE THROUGH THE SKIN AND DUE TO HOW ROUGH THE SUTURE PASSED AND NOT PULLING THROUGH AS EASILY AS USUAL, THE SURGEON LOOKED CLOSER AND NOTICED IT CAME OUT FRAYED ON THE OTHER SIDE. THE SURGEON OPENED A SUTURE FROM A BOX WITH DIFFERENT LOT AND IT WORKED FINE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535068 ↗
• MalfunctionApr 23, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SUTURE WAS PROTRUDING OUT OF THE PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990833 ↗
• MalfunctionMar 18, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847503 ↗
• MalfunctionMar 18, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847502 ↗
• MalfunctionMar 18, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847501 ↗
• MalfunctionMar 18, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847500 ↗
• MalfunctionMar 18, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847499 ↗
• MalfunctionJun 12, 2019Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS NOTED THAT THE WRONG SUTURE WAS INSIDE ONE PACK OF BOX OF 12. OUTSIDE LABEL SAYS J489 AND INSIDE SUTURE SAYS J544. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691279 ↗