Coated VICRYL J385HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031039476), received between Jan 22, 2020 and Jul 7, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. DURING THE SURGERY YESTERDAY, USED SUTURE TO SUTURE THE INCISION. HOWEVER, WHEN THE DOCTOR TIGHTENED THE SUTURE, SUTURE BROKE. LATER, THE SUTURE WAS REPLACED FOR SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25731800 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR RESECTION+FASCIA FLAP RECONSTRUCTION SURGERY DUE TO A SEBACEOUS NEVUS ON THE HEAD ON 7-SEP-2023 AND SUTURE WAS USED FOR SUBCUTANEOUS TENSION REDUCTION AND COSMETIC SUTURING. AFTER THE SURGERY, THE PATIENT RETURNED HOME. MORE THAN A MONTH AFTER SURGERY, THE PATIENT DISCOVERED ABNORMAL SECRETIONS IN THE HEAD AND CAME TO THE HOSPITAL FOR FOLLOW-UP. AFTER UNDERSTANDING THE PATIENT'S CONDITION, LOCAL DEBRIDEMENT AND SUTURE REMOVAL WERE PERFORMED ON THE 84TH DAY AFTER SURGERY. THE PATIENT WAS INSTRUCTED TO COME TO THE HOSPITAL TOMORROW TO CONTINUE DRESSING CHANGES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge

  MAUDE report 18319572 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN MASS RESECTION UNDER LOCAL ANESTHESIA DUE TO A CYST ON THE UPPER ARM ON (B)(6) 2023 AND SUTURE WAS USED FOR SUBCUTANEOUS TENSION REDUCTION AND COSMETIC SUTURING. POST-OP, THE PATIENT WAS DISCHARGED AND RETURNED HOME. ON THE 36TH DAY AFTER SURGERY, THE PATIENT DISCOVERED A RED LUMP IN THE UPPER ARM AND CAME TO THE HOSPITAL FOR FURTHER CONSULTATION. THE PATIENT HAD DEVICE EXTRUSION. AFTER UNDERSTANDING THE PATIENT'S CONDITION, LOCAL DEBRIDEMENT AND SUTURE REMOVAL WERE PERFORMED. FEEDBACK WAS PROVIDED 3 DAYS AFTER REMOVAL, AND THE HEALING WAS GOOD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Pocket Erosion

  MAUDE report 17904937 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION AND PLASTIC SURGERY FOR SKIN TUMORS ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO A "BACK PIGMENTED NEVUS" AND UNDERWENT THE PROCEDURE. THE SURGEON USED SUTURE FOR SUBCUTANEOUS TENSION REDUCTION AND COSMETIC SUTURING. POST-OP, THE PATIENT RETURNED HOME. AFTER 20 DAYS SINCE THE SURGERY, THE PATIENT'S FAMILY DISCOVERED A SUTURE ON THE BACK, AND THE PATIENT CAME TO THE HOSPITAL FOR FURTHER CONSULTATION. THE DEVICE EXTRUDED. AFTER THE DOCTOR LEARNED ABOUT THE PATIENT'S CONDITION, THE DOCTOR PERFORMED LOCAL DEBRIDEMENT AND SUTURE REMOVAL. THREE DAYS AFTER REMOVAL, THE PATIENT REPORTED GOOD HEALING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 17372404 ↗
• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CHERRY EYE REPAIR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. ONE WEEK POST-OPERATIVELY, THE PATIENT RETURNED AND UPON INSPECTION IT WAS FOUND THAT THE SUTURE HAD BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14380048 ↗
• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CHERRY EYE REPAIR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. ONE WEEK POST-OPERATIVELY, THE PATIENT RETURNED AND UPON INSPECTION IT WAS FOUND THAT THE SUTURE HAD BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14379671 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CHERRY EYE REPAIR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. UPON INSPECTION AT AN UNKNOWN TIME POST-OPERATIVELY, IT WAS FOUND THAT THE SUTURE HAD BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364788 ↗
• MalfunctionMay 27, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED TO CLOSE THE FASCIA. THE SUTURE BROKE DURING KNOT TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091894 ↗
• MalfunctionMay 27, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED TO CLOSE THE FASCIA. THE SUTURE WAS BROKEN WHEN HALF WAS THROUGH FASCIA WHEN TENTING THE TISSUE UP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091893 ↗
• MalfunctionApr 21, 2020Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9981301 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING DURING DEBRIDEMENT AND SUTURE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9618317 ↗