Coated VICRYL J422HRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705031039735), received between Jul 1, 2019 and Apr 21, 2026 — classified as 6 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DEBRIDEMENT AND SUTURING PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHILE PERFORMING DEBRIDEMENT AND SUTURING ON THE PATIENT, THE CIRCULATING NURSE OPENED THE SUTURE AND FOUND THAT IT WAS EXTREMELY BRITTLE AND COULD BREAK WITH JUST A SLIGHT PULL, MAKING IT UNSUITABLE FOR SUTURING. IMMEDIATELY REPLACED IT WITH A NEW SUTURE FOR SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938892 ↗
• MalfunctionFeb 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 11:30, WHILE SUTURING THE PATIENT'S SKIN DURING SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR UNPACKED A NEW SUTURE AND CONTINUED TO SUTURE IT. THE NEEDLE HAS BEEN RETAINED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393538 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT ENTERED THE OPERATING ROOM AT 12:45 TO UNDERGO SURGERY. WHEN CLOSING THE SUTURED SKIN, THE LEAD SURGEON EXPERIENCED THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE WHILE USING A STERILE MEDICAL NEEDLE. AFTER THE INTEGRITY OF THE NEEDLE WAS CHECKED BY THE LEAD SURGEON, HAND WASHING NURSE, AND TOURING NURSE, A NEW NEEDLE WAS IMMEDIATELY GIVEN TO CONTINUE SUTURING WITHOUT AFFECTING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241414 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. DURING THE PROCESS OF SUTURING THE SKIN, THE SUTURE SUDDENLY BROKE. THE DOCTOR IMMEDIATELY REPLACED IT AND RE SUTURED IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439399 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE AND NEEDLESS ARE DISCONNECTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298347 ↗
• MalfunctionSep 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURES ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE AND SUTURE SEPARATED DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293089 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW WOUND. 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 19917498 ↗
• MalfunctionJun 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT GENERAL SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE GENERAL SURGEON WAS STITCHING UP AN INCISION WHEN THE THREAD CAME OFF FROM THE NEEDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500955 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION DUE TO RELATIVE HEAD PELVIC IMBALANCE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROCEDURE WAS SMOOTH. ON THE 4TH DAY AFTER SURGERY, IT WAS FOUND THAT THE ABDOMINAL INCISION WAS SLIGHTLY RED, AND A HARD LUMP COULD BE PALPATED ON THE UPPER LEFT SIDE WITHOUT EXUDATION. THE PATIENT HAD POST OP INFLAMMATION. THE DOCTOR CONSIDERED THE SURGICAL INCISION AND THE HARD LUMP TO BE RED, AND PROVIDED ANTI INFECTION, SURGICAL MOUTH APPLICATION OF MIRABILITE, SPECTRUM THERAPY, AND OTHER TREATMENTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Insufficient Information

  MAUDE report 19062585 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED BECAUSE THE PATIENT UNDERWENT SURGERY DUE TO PREMATURE RUPTURE OF THE MEMBRANES AND PRESENTATION OF THE BUTTOCKS. AFTER THE SURGERY, THE DOCTOR USED SUTURE TO SEW THE INCISION, AND THE PROCEDURE WAS SMOOTH WITHOUT ANY SPECIAL COMPLICATIONS. ON THE 8TH DAY AFTER SURGERY, THE PATIENT DISCOVERED REDNESS, SWELLING, INFLAMMATION AND INDURATION IN THE ABDOMINAL INCISION. THE PATIENT APPLIED BAIDUOBANG OINTMENT AND MIRABILITE EXTERNALLY ON THEIR OWN. THE EFFECT IS NOT SATISFACTORY AFTER TREATMENT. ON THE 11TH DAY AFTER SURGERY, THERE WAS YELLOW PURULENT DISCHARGE ON THE INCISION, AND NO BLOOD LEAKAGE WAS OBSERVED. IT IS PLANNED TO BE ADMITTED TO THE HOSPITAL FOR TREATMENT DUE TO POOR POSTOPERATIVE ABDOMINAL INCISION HEALING. IMPROVE BLOOD ROUTINE AND BACTERIAL CULTURE TO PREVENT AND TREAT INFECTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Inflammation; Purulent Discharge; Skin Inflammation/ Irritation; Swelling/ Edema; Unspecified Infection

  MAUDE report 17143783 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE POSTOPERATIVE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S INCISION, ENSURING A SMOOTH SURGICAL PROCESS WITHOUT ANY SPECIAL COMPLICATIONS. ON THE 24TH DAY AFTER SURGERY, THE PATIENT DISCOVERED FLUID LEAKAGE FROM THE ABDOMINAL INCISION, WITHOUT REDNESS, SWELLING, OR BLEEDING. IT WAS CONSIDERED THAT THE POSTOPERATIVE ABDOMINAL WALL INCISION HEALING WAS POOR, AND HOSPITALIZATION WAS RECOMMENDED, BUT THE PATIENT REFUSED. THE PATIENT WAS INSTRUCTED TO APPLY BAIDUOBANG AND RECOMBINANT BOVINE BASIC FIBROBLAST GROWTH FACTOR GEL EXTERNALLY AND FOLLOW UP REGULARLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 17142935 ↗
• MalfunctionOct 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE RIPS OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662934 ↗
• MalfunctionOct 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE RIPS OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662648 ↗
• MalfunctionOct 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE RIPS OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662611 ↗
• MalfunctionOct 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE RIPS OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662587 ↗
• MalfunctionOct 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE RIPS OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662210 ↗
• MalfunctionOct 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE THREAD SEPARATION OCCURRED AFTER OPENING THE OUTER PACKAGE. THE PRODUCT IS NOT USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655189 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING PERITONEAL ADIPOSE TISSUE, THREAD IS BROKEN DURING KNOTTING, AND THE BROKEN PART IS THE SUTURE BODY, AND THE NEEDLE DOES NOT FALL INTO THE PATIENT'S BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414912 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING PERITONEAL ADIPOSE TISSUE, THREAD IS BROKEN DURING KNOTTING, AND THE BROKEN PART IS THE SUTURE BODY, AND THE NEEDLE DOES NOT FALL INTO THE PATIENT'S BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414911 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING PERITONEAL ADIPOSE TISSUE, THREAD IS BROKEN DURING KNOTTING, AND THE BROKEN PART IS THE SUTURE BODY, AND THE NEEDLE DOES NOT FALL INTO THE PATIENT'S BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414908 ↗
• MalfunctionAug 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING SEWING SKIN IN SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DOCTOR AND NURSE ON THE OPERATING TABLE VERIFIED THAT THE SUTURE HAD NOT BEEN CLAMPED WITH NEEDLE FORCEPS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195874 ↗
• InjuryJun 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. THE PATIENT RECOVERED AND WAS DISCHARGED ON THE 5TH DAY AFTER SURGERY . ON THE 15TH DAY AFTER SURGERY , THE PATIENT FOUND A LITTLE EXUDATION AT THE ABDOMINAL OPERATION PORT AND WENT TO THE HOSPITAL FOR EXAMINATION. IT CAN BE SEEN THAT 1/4 OF THE ABDOMINAL SURGICAL SITE IS RED, WITH LIGHT YELLOW SECRETION FLOWING OUT. AFTER THE DOCTOR GIVES THE SECRETION BACTERIAL CULTURE + DRUG SENSITIVITY EXAMINATION, THE WOUND DRESSING IS CHANGED. EXTERNAL APPLICATION OF BAIDUOBANG, ABDOMINAL INCISION FREQUENCY SPECTRUM AND STRENGTHENING ANTI-INFLAMMATORY TREATMENT.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 14824892 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL GRAFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER THE PROCEDURE AFTER THEY PLACE THE SUTURE IN THE DOGS MOUTH, IT BECOMES SOFT IN ONE WEEK. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631722 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL GRAFT PROCEDURE ON AN UNKNOWN DATE ON AND SUTURE WAS USED. AFTER THE PROCEDURE IT WAS NOTED THE SUTURE IN DOGS MOUTH, IT BECOMES SOFT IN ONE WEEK.. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627812 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL GRAFT PROCEDURE ON AN UNKNOWN DATE ON AND SUTURE WAS USED. AFTER THE PROCEDURE IT WAS NOTED THE SUTURE IN DOGS MOUTH, IT BECOMES SOFT IN ONE WEEK. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627780 ↗