Coated VICRYL J304HRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10705031038615), received between May 7, 2019 and Sep 30, 2026 — classified as 13 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948186 ↗
• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948167 ↗
• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947929 ↗
• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947917 ↗
• MalfunctionJul 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026, AND SUTURE WAS USED. THE NEEDLE ISOLATE FROM SUTURE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25731764 ↗
• MalfunctionJan 7, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE SUTURING PROCESS, THE VICRYL 4-0 SUTURE BECAME INADVERTENTLY ENTANGLED, RESULTING IN RUPTURE WHEN TRACTION WAS APPLIED. WE DO NOT HAVE VIDEOS OF THE INCIDENT, ONLY A PHOTO OF THE SUTURE THAT WAS REPLACED AFTER THE FAILURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992568 ↗
• MalfunctionDec 26, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE SUTURE CAME OFF THE NEEDLE. NO PATIENT CONSEQUENCE WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897089 ↗
• MalfunctionOct 30, 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 AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424693 ↗
• MalfunctionOct 30, 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 AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424677 ↗
• MalfunctionOct 30, 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 AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424266 ↗
• MalfunctionOct 30, 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 AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424255 ↗
• MalfunctionOct 23, 2025Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem; Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE WHICH IS PURCHASED ON (B)(6), WHEN USED IT TODAY, ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. THIS HAS HAPPENED TO ONE SUTURE OUT OF 36 PACKAGES SO FAR. THE CUSTOMER IS WORRIED THAT SOMETHING SIMILAR WILL HAPPEN AGAIN. IT WILL BE RETURNING THE DEFECTIVE PRODUCT AND ALL THE REMAINING ITEMS, SO PLEASE INVESTIGATE THE CAUSE. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23366673 ↗
• MalfunctionOct 23, 2025Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem; Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE WHICH IS PURCHASED ON (B)(6), WHEN USED IT TODAY, ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. THIS HAS HAPPENED TO ONE SUTURE OUT OF 36 PACKAGES SO FAR. THE CUSTOMER IS WORRIED THAT SOMETHING SIMILAR WILL HAPPEN AGAIN. IT WILL BE RETURNING THE DEFECTIVE PRODUCT AND ALL THE REMAINING ITEMS, SO PLEASE INVESTIGATE THE CAUSE. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23366656 ↗
• MalfunctionOct 23, 2025Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem; Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE WHICH IS PURCHASED ON JULY 1ST, WHEN USED IT TODAY, ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. THIS HAS HAPPENED TO ONE SUTURE OUT OF 36 PACKAGES SO FAR. THE CUSTOMER IS WORRIED THAT SOMETHING SIMILAR WILL HAPPEN AGAIN. IT WILL BE RETURNING THE DEFECTIVE PRODUCT AND ALL THE REMAINING ITEMS, SO PLEASE INVESTIGATE THE CAUSE. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23366655 ↗
• MalfunctionOct 23, 2025Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem; Defective Component; Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE WHICH IS PURCHASED ON JULY 1ST, WHEN USED IT TODAY, ABOUT TWO-THIRDS OF THE SUTURE COLOR WAS MIXED WITH WHITE IN PATCHES. THIS HAS HAPPENED TO ONE SUTURE OUT OF 36 PACKAGES SO FAR. THE CUSTOMER IS WORRIED THAT SOMETHING SIMILAR WILL HAPPEN AGAIN. IT WILL BE RETURNING THE DEFECTIVE PRODUCT AND ALL THE REMAINING ITEMS, SO PLEASE INVESTIGATE THE CAUSE. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23366654 ↗
• InjuryMay 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PICC LINE INSERTION ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, ON (B)(6) 2025, THE PATIENT NOTED PURULENT DRAINAGE AT THE INSERTION SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR PORT INSERTION SITE INFECTION. THE SUTURE WAS TRIMMED PREVIOUSLY. IT WAS OPINED BY THE SURGEON THAT THERE COULD HAVE BEEN DELAYED SUTURE ABSORPTION. NO FURTHER PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 22090923 ↗
• MalfunctionFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A VOLUNTEER SURGEON REPORTED THAT THE SUTURE DETACHED FROM THE NEEDLE DURING THE PROCEDURE SHE PERFORMED. THIS ISSUE DID NOT RESULT IN ANY ADVERSE OUTCOMES OR COMPROMISE THE SAFETY OF THE PATIENT AT ANY POINT DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368060 ↗
• MalfunctionFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A VOLUNTEER SURGEON REPORTED THAT THE SUTURE DETACHED FROM THE NEEDLE DURING THE PROCEDURE SHE PERFORMED. THIS ISSUE DID NOT RESULT IN ANY ADVERSE OUTCOMES OR COMPROMISE THE SAFETY OF THE PATIENT AT ANY POINT DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368056 ↗
• MalfunctionFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A VOLUNTEER SURGEON REPORTED THAT THE SUTURE DETACHED FROM THE NEEDLE DURING THE PROCEDURE SHE PERFORMED. THIS ISSUE DID NOT RESULT IN ANY ADVERSE OUTCOMES OR COMPROMISE THE SAFETY OF THE PATIENT AT ANY POINT DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368052 ↗
• MalfunctionJan 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095290 ↗
• InjuryOct 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. LATER, IT WAS NOTICED THAT THE SUTURES USED WERE NOT DEGRADING AS QUICKLY AS USUAL, CAUSING A FOREIGN BODY REACTION IN THE OROPHARYNGEAL PILLARS. THE PATIENT MAY HAVE AN INTENSE CASE THAT WILL BE TAKEN TO THE OPERATING ROOM TO REMOVE SUTURES. THE PATIENT IS GENERATING AN INTENSE INFLAMMATORY REACTION WITH FOUL SECRETION AND ERYTHEMA OF THE AREA AROUND THE SUTURE 4 WEEKS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Foreign Body Reaction; Inflammation; Local Reaction; Purulent Discharge

  MAUDE report 20368701 ↗
• InjuryOct 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. LATER, IT WAS NOTICED THAT THE SUTURES USED WERE NOT DEGRADING AS QUICKLY AS USUAL, CAUSING A FOREIGN BODY REACTION IN THE OROPHARYNGEAL PILLARS. THE PATIENT MAY HAVE AN INTENSE CASE THAT WILL BE TAKEN TO THE OPERATING ROOM TO REMOVE SUTURES. THE PATIENT IS GENERATING AN INTENSE INFLAMMATORY REACTION WITH FOUL SECRETION AND ERYTHEMA OF THE AREA AROUND THE SUTURE 4 WEEKS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Foreign Body Reaction; Inflammation; Local Reaction; Purulent Discharge

  MAUDE report 20368692 ↗
• InjuryOct 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. LATER, IT WAS NOTICED THAT THE SUTURES USED WERE NOT DEGRADING AS QUICKLY AS USUAL, CAUSING A FOREIGN BODY REACTION IN THE OROPHARYNGEAL PILLARS. THE PATIENT MAY HAVE AN INTENSE CASE THAT WILL BE TAKEN TO THE OPERATING ROOM TO REMOVE SUTURES. THE PATIENT IS GENERATING AN INTENSE INFLAMMATORY REACTION WITH FOUL SECRETION AND ERYTHEMA OF THE AREA AROUND THE SUTURE 4 WEEKS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Foreign Body Reaction; Inflammation; Local Reaction; Purulent Discharge

  MAUDE report 20368691 ↗
• InjuryOct 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. LATER, IT WAS NOTICED THAT THE SUTURES USED WERE NOT DEGRADING AS QUICKLY AS USUAL, CAUSING A FOREIGN BODY REACTION IN THE OROPHARYNGEAL PILLARS. THE PATIENT MAY HAVE AN INTENSE CASE THAT WILL BE TAKEN TO THE OPERATING ROOM TO REMOVE SUTURES. THE PATIENT IS GENERATING AN INTENSE INFLAMMATORY REACTION WITH FOUL SECRETION AND ERYTHEMA OF THE AREA AROUND THE SUTURE 4 WEEKS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Foreign Body Reaction; Inflammation; Local Reaction; Purulent Discharge

  MAUDE report 20368683 ↗
• InjuryOct 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. LATER, IT WAS NOTICED THAT THE SUTURES USED WERE NOT DEGRADING AS QUICKLY AS USUAL, CAUSING A FOREIGN BODY REACTION IN THE OROPHARYNGEAL PILLARS. THE PATIENT MAY HAVE AN INTENSE CASE THAT WILL BE TAKEN TO THE OPERATING ROOM TO REMOVE SUTURES. THE PATIENT IS GENERATING AN INTENSE INFLAMMATORY REACTION WITH FOUL SECRETION AND ERYTHEMA OF THE AREA AROUND THE SUTURE 4 WEEKS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Foreign Body Reaction; Inflammation; Local Reaction; Purulent Discharge

  MAUDE report 20368682 ↗