Coated VICRYL J546GRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031041097), received between Jul 31, 2019 and Jan 27, 2025 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Component Misassembled; Component Misassembled

  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 A SALES REP THAT, THE PRODUCT WAS SUPPOSED TO BE A DOUBLE-ARMED SUTURE, BUT ONE SIDE OF THE NEEDLE WAS NOT IN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245931 ↗
• MalfunctionOct 3, 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 SUTURE WAS DETACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358102 ↗
• MalfunctionAug 20, 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 NEEDLE AND THREAD BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001604 ↗
• MalfunctionJun 12, 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 SUTURE AND NEEDLE SEPARATED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519047 ↗
• MalfunctionJun 12, 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 SUTURE AND NEEDLE SEPARATED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519041 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY (BILATERAL) ON (B)(6) 2023 AND SUTURE WAS USED. THE PRODUCT HAD PROBLEMS SINCE IT WAS CUT WHEN MAKING A STITCH. IT COULD NOT BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003171 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY (BILATERAL) (B)(6) 2023 AND SUTURE WAS USED. THE PRODUCT HAD PROBLEMS SINCE THE THREAD CAME OUT OF THE NEEDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003169 ↗
• MalfunctionOct 16, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE OF THIS SUTURE HAVE COME APART AND BEING UNUSABLE. NO REPORTED ADVERSE PATIENT CONSEQUENCES. UPON RECEIPT AND ANALYSIS, THE NEEDLE BREAK WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946548 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE EASILY DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519456 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE EASILY DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519313 ↗
• MalfunctionSep 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHEN PASSING THE POINT, THE SUTURE BURSTS AND THE NEEDLE WAS DISASSEMBLED. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349713 ↗
• MalfunctionSep 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHEN PASSING THE POINT, THE SUTURE BURSTS AND THE NEEDLE WAS DISASSEMBLED. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349619 ↗
• MalfunctionSep 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHEN PASSING THE POINT, THE SUTURE BURSTS AND THE NEEDLE WAS DISASSEMBLED. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349613 ↗
• MalfunctionJan 21, 2022Device 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. IT WAS NOTED THAT THERE WAS FOREIGN MATTER ON THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13323752 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE PULLING THE FIRST STITCH, THE THREAD BREAKS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910553 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VITRECTOMY AND/OR PLAQUE BRACHYTHERAPY PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED FOR CONJUNCTIVAL AND/OR SCLERAL CLOSURE. IT WAS REPORTED THAT THERE HAS BEEN NO CHANGE TO SUTURE TECHNIQUE. THERE WERE NO DEFICIENCIES NOTED WITH THE SUTURE SEEN IN THE OR. THE PATIENT DEVELOPED EARLY POST-OPERATIVE GRANULOMA, INFLAMMATION AND WAS TREATED WITH AGGRESSIVE TOPICAL STEROIDS AT 1 WEEK OR 1 MONTH VISITS. THE PATIENT HAS IMPROVED WITH TOPICAL STEROIDS BUT REQUIRED MORE FREQUENT CLINIC VISITS AND TOPICAL THERAPY. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 11136772 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VITRECTOMY AND/OR PLAQUE BRACHYTHERAPY PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED FOR CONJUNCTIVAL AND/OR SCLERAL CLOSURE. IT WAS REPORTED THAT THERE HAS BEEN NO CHANGE TO SUTURE TECHNIQUE. THERE WERE NO DEFICIENCIES NOTED WITH THE SUTURE SEEN IN THE OR. THE PATIENT DEVELOPED EARLY POST-OPERATIVE GRANULOMA, INFLAMMATION AND WAS TREATED WITH AGGRESSIVE TOPICAL STEROIDS AT 1 WEEK OR 1 MONTH VISITS. THE PATIENT HAS IMPROVED WITH TOPICAL STEROIDS BUT REQUIRED MORE FREQUENT CLINIC VISITS AND TOPICAL THERAPY. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 11136768 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VITRECTOMY AND/OR PLAQUE BRACHYTHERAPY PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED FOR CONJUNCTIVAL AND/OR SCLERAL CLOSURE. IT WAS REPORTED THAT THERE HAS BEEN NO CHANGE TO SUTURE TECHNIQUE. THERE WERE NO DEFICIENCIES NOTED WITH THE SUTURE SEEN IN THE OR. THE PATIENT DEVELOPED EARLY POST-OPERATIVE GRANULOMA, INFLAMMATION AND WAS TREATED WITH AGGRESSIVE TOPICAL STEROIDS AT 1 WEEK OR 1 MONTH VISITS. THE PATIENT HAS IMPROVED WITH TOPICAL STEROIDS BUT REQUIRED MORE FREQUENT CLINIC VISITS AND TOPICAL THERAPY. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 11136766 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VITRECTOMY AND/OR PLAQUE BRACHYTHERAPY PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED FOR CONJUNCTIVAL AND/OR SCLERAL CLOSURE. IT WAS REPORTED THAT THERE HAS BEEN NO CHANGE TO SUTURE TECHNIQUE. THERE WERE NO DEFICIENCIES NOTED WITH THE SUTURE SEEN IN THE OR. THE PATIENT DEVELOPED EARLY POST-OPERATIVE GRANULOMA, INFLAMMATION AND WAS TREATED WITH AGGRESSIVE TOPICAL STEROIDS AT 1 WEEK OR 1 MONTH VISITS. THE PATIENT HAS IMPROVED WITH TOPICAL STEROIDS BUT REQUIRED MORE FREQUENT CLINIC VISITS AND TOPICAL THERAPY. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 11136764 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VITRECTOMY AND/OR PLAQUE BRACHYTHERAPY PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED FOR CONJUNCTIVAL AND/OR SCLERAL CLOSURE. IT WAS REPORTED THAT THERE HAS BEEN NO CHANGE TO SUTURE TECHNIQUE. THERE WERE NO DEFICIENCIES NOTED WITH THE SUTURE SEEN IN THE OR. THE PATIENT DEVELOPED EARLY POST-OPERATIVE GRANULOMA, INFLAMMATION AND WAS TREATED WITH AGGRESSIVE TOPICAL STEROIDS AT 1 WEEK OR 1 MONTH VISITS. THE PATIENT HAS IMPROVED WITH TOPICAL STEROIDS BUT REQUIRED MORE FREQUENT CLINIC VISITS AND TOPICAL THERAPY. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 11136754 ↗
• MalfunctionJul 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EYE SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10330064 ↗
• MalfunctionJul 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EYE SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE ALONG THE LENGTH OF THE THREAD. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10330060 ↗
• MalfunctionJul 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, SUTURE WAS BROKEN IN A ROW DURING CONTINUOUS SUTURING. ANOTHER LIKE SUTURE WITH ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305519 ↗
• MalfunctionJul 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, SUTURE WAS BROKEN IN A ROW DURING CONTINUOUS SUTURING. ANOTHER LIKE SUTURE WITH ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305514 ↗
• MalfunctionJul 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, SUTURE WAS BROKEN IN A ROW DURING CONTINUOUS SUTURING. ANOTHER LIKE SUTURE WITH ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305507 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc