Coated VICRYL J335HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031038950), received between Aug 31, 2021 and Jun 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APPENDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE POP OFF AT THE SWAGE DURING FASCIAL SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140882 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN (B)(6) 2024 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF WHEN IN USE, AND WAS THEN FOUND ON THE PATIENT DRAPE. SURGEON WAS PREPARING A STANDARD STITCH AT THE TIME OF USE WITH NO EXCESSIVE FORCE OR PRESSURE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350911 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APPENDECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON WAS STITCHING AN ANCHOR SUTURE FOR THE HASSON CANNULA AS SHE NORMALLY DOES. SUTURE NEEDLE SNAPPED AND BROKE IN HALF. THE SURGEON HAD TO RETRIEVE THE BROKEN PIECE WITH THE AID OF X-RAY. THE SURGERY WAS DELAYED 45 MIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479922 ↗
• MalfunctionOct 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USING ON THE PATIENT, THE CUSTOMER INFORMS THAT THE PACKAGING OF EACH SUTURE IN THE BOX ARE OPENED. OR VERY EASY TO OPEN. AS THEY HAVE NOT BEEN SEALED CORRECTLY IN THE PRODUCTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581396 ↗
• MalfunctionOct 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USING ON THE PATIENT, THE CUSTOMER INFORMS THAT THE PACKAGING OF EACH SUTURE IN THE BOX ARE OPENED. OR VERY EASY TO OPEN. AS THEY HAVE NOT BEEN SEALED CORRECTLY IN THE PRODUCTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581390 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. UPON CLOSING OF THE UMBILICUS LAP INCISION, THE NEEDLE ON THE SUTURE BROKE INTO 2 PIECES. A PART OF THE NEEDLE, WHICH INCLUDED THE TIP WAS STUCK IN THE PATIENT AND THE OTHER PART WHICH WAS STILL ATTACHED TO THE SUTURE THREAD WAS REMOVED. VARIOUS STEPS WERE REQUIRED TO LOCATE AND REMOVE THE NEEDLE INCLUDING X-RAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13299152 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE NEEDLE BROKE FIRST PASS AFTER LOADING CORRECTLY SEWING UP AN UMBILICAL INCISION FOR A PORT. IT HAD NOT BEEN USED OR BENT PREVIOUSLY AND WAS NOT WIELDED IN SUCH A WAY TO CAUSE UNDUE STRESS ON THE ITEM. THE BROKEN END WAS RETRIEVED, AND NO HARM WAS CAUSED TO PATIENT OR SURGEON. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12396298 ↗