Coated VICRYL J103GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031037809), received between Jul 8, 2024 and Aug 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE ISSUE HAS OCCURRED, THE PACKAGE WAS DIRTY WHEN PREPARING THE PRODUCT TO USE IN SURGERY AND THE J103 BOX WAS OPENED AND THE PACKAGE WAS CHECKED. THE PRODUCT COULD NOT BE USED IN THE OPERATION. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860346 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BECAME LOOSE AT THE BEGINNING IN LIGATING BLOOD VESSELS. THERE WAS NO SURGICAL DELAY. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697111 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BECAME LOOSE AT THE BEGINNING IN LIGATING BLOOD VESSELS. THERE WAS NO SURGICAL DELAY. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697065 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BECAME LOOSE AT THE BEGINNING IN LIGATING BLOOD VESSELS. THERE WAS NO SURGICAL DELAY. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696966 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED AN UNKNOWN SURGERY ON (B)(6)2024 AND SUTURE WAS USED. THE SUTURE BECAME LOOSE AT THE BEGINNING IN LIGATING BLOOD VESSELS. THERE WAS NO SURGICAL DELAY. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696962 ↗
• MalfunctionJul 8, 2024Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BECAME LOOSE AT THE BEGINNING IN LIGATING BLOOD VESSELS. THERE WAS NO SURGICAL DELAY. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696923 ↗