Coated VICRYL J397HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031039575), received between Oct 2, 2018 and Jul 29, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074800 ↗
• MalfunctionJun 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE EMPLOYEE THAT THE NEEDLE SNAPPED AT THE DEMARCATION. NO OTHER INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100293 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER UTERINE SEGMENT CESAREAN SECTION ON (B)(6) 2022 AND SUTURE WAS USED FOR SUTURING THE SKIN. THE INTRAOPERATIVE SUTURING WAS SMOOTH. ON (B)(6) 2022, THE DOCTOR FOUND DURING WARD ROUND THAT THE PATIENT HAD PALE BLOODY EXUDATION WHEN SQUEEZING THE INCISION, WITHOUT OTHER SPECIAL SYMPTOMS AND SIGNS. THE PATIENT WAS GIVEN INCISION GAUZE DRAINAGE AND DRESSING CHANGE. ON (B)(6) 2022, THE PATIENT STILL HAD PALE BLOODY EXUDATION IN THE INCISION, WITHOUT OTHER SPECIAL SYMPTOMS OR SIGNS. THE DOCTOR GAVE THE PATIENT EXTENDED WOUND DEBRIDEMENT AND DRESSING CHANGE. ON (B)(6) 2022, THE PATIENT'S INCISION EXUDATION WAS REDUCED, AND THE PATIENT WAS GIVEN DEBRIDEMENT AND SUTURING OF ABDOMINAL WALL INCISION UNDER SPINAL ANESTHESIA. DURING THE OPERATION, THE SUTURE OF THE ORIGINAL ABDOMINAL WALL INCISION USED FOR SUTURING THE ANTERIOR RECTUS SHEATH WAS FOUND BROKEN IN THE MIDDLE. AFTER THE DOCTOR CLEANED THE WOUND WITH NORMAL SALINE, THE WOUND WAS SCRAPED WITH VASCULAR FORCEPS, AND THE ANTERIOR RECTUS SHEATH WAS CONTINUOUSLY SUTURED WITH SILK SUTURE AND THE SKIN AND SUBCUTANEOUS TISSUES WERE INTERMITTENTLY SUTURED. THE PATIENT WAS IN STABLE CONDITION CUR

  Patient problems: Fluid Discharge

  MAUDE report 14854783 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT A CAT UNDERWENT A SPAY PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. THERE WAS NO OBVIOUS PRODUCT DEFECT OBSERVED AT TIME OF PROCEDURE. ON POST- OP DAY 6, THE SUTURE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386871 ↗
• MalfunctionAug 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423679 ↗
• MalfunctionJun 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN SEWING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178846 ↗
• MalfunctionDec 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LATERAL EPISIOTOMY SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. ON (B)(6) 2019, THE SUTURE BROKE AND INCISION SPLIT AFTER SURGERY, INCLUDING MUSCLE LAYER AND SKIN. THE WOUND HAS INFLAMMATION, WHITE SECRETION AND NO ERYTHEMA. THE PATIENT WAS TREATED WITH REMOVAL OF THE SUTURE AND A SITTING BATH WITH POTASSIUM PERMANGANATE TWICE A DAY. AFTER SEVEN DAYS, THE PATIENT CONDITION CHANGED TO BETTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 9411014 ↗
• InjuryDec 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LATERAL EPISIOTOMY ON (B)(6) 2019 AND SUTURE WAS USED. EIGHT DAYS AFTER THE SURGERY, THE SUTURE BROKE AND THE INCISION SPLIT. THE WOUND HAD PUS BUT WITH NO INFLAMMATION AND NO ERYTHEMA. THE PATIENT WAS TREATED WITH REMOVAL OF THE SUTURE, DEBRIDEMENT, AND A SITTING BATH WITH POTASSIUM PERMANGANATE TWICE A DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Purulent Discharge; Wound Dehiscence

  MAUDE report 9410532 ↗
• MalfunctionMay 29, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUBO-OVARIAN LYSIS PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. SUTURE BREAKAGE OCCURRED DURING THE PROCEDURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8652522 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EPISIOTOMY ON (B)(6) 2018 AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT¿S INCISION HEALING WAS BAD, SPLIT, ABNORMAL INCISION GRANULATION. THERE WAS NO SWELLING, NO PUS. THE SURGEON REMOVED SUTURE AND DID NOT RE-SUTURE. THE PATIENT UNDERWENT DAILY BATH WITH POTASSIUM PERMANGANATE, ONE WEEK AFTER HEALING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Not Applicable; Wound Dehiscence

  MAUDE report 7927811 ↗
• InjuryOct 2, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EPISIOTOMY ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE BROKE 10 DAYS AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT¿S INCISION HEALING WAS BAD, SPLIT. THERE WAS NO SWELLING OR PUS. THE SURGEON REMOVED THE SUTURE AND DID NOT RE-SUTURE. THE PATIENT UNDERWENT DAILY BATH WITH POTASSIUM PERMANGANATE. IT WAS REPORTED THAT THE PATIENT HEALED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Not Applicable; Wound Dehiscence

  MAUDE report 7927430 ↗