Coated VICRYL J358HRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10705031039254), received between Oct 2, 2018 and Aug 17, 2026 — classified as 6 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Break

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274295 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON USE J358H ,SUTURE WAS BROKEN CAN NOT USE DURING OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319742 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON USE J358H, SUTURE WAS BROKEN CAN NOT USE DURING OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319484 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON USE J358H ,SUTURE WAS BROKEN CAN NOT USE DURING OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319480 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON USE J358H ,SUTURE WAS BROKEN CAN NOT USE DURING OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319478 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON USE J358H ,SUTURE WAS BROKEN CAN NOT USE DURING OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319477 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON USE J358H ,SUTURE WAS BROKEN CAN NOT USE DURING OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319462 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE SURGICAL SUTURING OF THE UTERINE MUSCLE, THE DOCTOR FOUND THAT THE SUTURE WAS PRONE TO TEARING AND BREAKING WHEN KNOTTED, AND NEW SUTURE NEEDED TO BE ADDED FOR RE SUTURING. THIS EVENT INCREASED THE PATIENT'S RISK OF BLEEDING AND PROLONGED THE SURGICAL DURATION. THE DISCARDED SUTURE HAS BEEN TREATED AS MEDICAL WASTE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085502 ↗
• MalfunctionApr 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THE NEEDLE AND THREAD SEPARATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766453 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BROKE MID LENGTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299955 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN LABOR AND DELIVERY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING AN UNKNOWN LABOR AND DELIVERY PROCEDURE THAT THE TIP OF THE NEEDLE BROKE OFF. FRAGMENT WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EVENT DEVICE AND UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643517 ↗
• MalfunctionNov 7, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. THE SEAL WAS FOUND UNTIGHT WHEN OPENED TO PREPARE FOR SURGERY. THE CUSTOMER SUSPECTED THAT THE SEAL OF THE PACKAGE ISN'T TIGHT. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT IS UNAVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628957 ↗
• MalfunctionSep 25, 2024Material Discolored; Appropriate Device Problem Term/Code Not Available; Material Discolored; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS FOUND OXIDATION IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. BESIDES, THE SUTURE COLOR WAS DIFFERENT FROM THAT OF THE NORMAL ONE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302029 ↗
• InjuryJul 24, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY IN HOSPITAL ON (B)(6) 2023 AND SUTURE WAS USED FOR MUSCLE AND JOINT CAPSULE SEWING IN A CONTINUOUS SUTURING MANNER. THE INTRAOPERATIVE SEWING OPERATION WAS SMOOTH. ABOUT 28 DAYS AFTER THE SURGERY, THE DOCTOR FOUND THAT THE PATIENT HAD WOUND EXUDATION AND LOCAL FLUCTUATION OF WOUND, AND THE INCISION DEHISCED. THE DOCTOR PERFORMED THE SECOND SURGERY, AND ONLY A FEW KNOTS REMAINED IN PREVIOUS SEWING SITE OF THE JOINT CAPSULE AND FASCIA. THE DOCTOR THEN REMOVED THE RESIDUAL SUTURE AND PERFORMED DEBRIDEMENT AND REPLACED IT WITH A NEW DIFFERENT TYPE OF ABSORBABLE SUTURE. AFTER SYMPTOMATIC TREATMENT, THE PATIENT'S INCISION HEALING WAS IMPROVED, AND NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing; Wound Dehiscence

  MAUDE report 19818094 ↗
• MalfunctionJul 9, 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 SEPARATED. CHANGED TO ANOTHER BATCH OF SUTURE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706346 ↗
• MalfunctionJul 9, 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 SEPARATED. CHANGED TO ANOTHER BATCH OF SUTURE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706287 ↗
• MalfunctionJul 9, 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 SEPARATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706269 ↗
• MalfunctionJul 9, 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 SEPARATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705998 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE NEEDLE AND THREAD SEPARATED. DIFFERENT DOCTORS USED THE BATCH NUMBER WAS BROKEN FOR MORE THAN 5 PACKAGES. USE ANOTHER LOT OF SUTURES TO COMPLETE THE SURGERY WITHOUT ANY PROBLEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532910 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE NEEDLE AND THREAD SEPARATED. DIFFERENT DOCTORS USED THE BATCH NUMBER WAS BROKEN FOR MORE THAN 5 PACKAGES. USE ANOTHER LOT OF SUTURES TO COMPLETE THE SURGERY WITHOUT ANY PROBLEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532612 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE NEEDLE AND THREAD SEPARATED. DIFFERENT DOCTORS USED THE BATCH NUMBER WAS BROKEN FOR MORE THAN 5 PACKAGES. USE ANOTHER LOT OF SUTURES TO COMPLETE THE SURGERY WITHOUT ANY PROBLEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532593 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE NEEDLE AND THREAD SEPARATED. DIFFERENT DOCTORS USED THE BATCH NUMBER WAS BROKEN FOR MORE THAN 5 PACKAGES. USE ANOTHER LOT OF SUTURES TO COMPLETE THE SURGERY WITHOUT ANY PROBLEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532542 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE NEEDLE AND THREAD SEPARATED. DIFFERENT DOCTORS USED THE BATCH NUMBER WAS BROKEN FOR MORE THAN 5 PACKAGES. USE ANOTHER LOT OF SUTURES TO COMPLETE THE SURGERY WITHOUT ANY PROBLEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532349 ↗
• MalfunctionMay 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY . CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19424135 ↗
• MalfunctionApr 19, 2024Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. PRIOR TO USE, WHEN OPENED, THE STITCHES WERE NOT FIXED, AND THE COLOR OF THE STITCHES WAS WEIRD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, SUTURE DEGRADATION WAS OBSERVED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146207 ↗