Coated VICRYL J944HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031043640), received between Jun 24, 2021 and Dec 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE MD WAS SUTURING THE VAGINA. THE SUTURE CAME OFF THE NEEDLE DRIVER, WHEN THEY WENT TO PULL BACK ON THE SUTURE TO RETRIEVE THE NEEDLE, SUTURE CAME APART FROM NEEDLE, THE NEEDLE WAS STUCK IN THE TISSUE AND HAD TO BE FOUND. NO PATIENT HARM. IT WAS RETRIEVED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357997 ↗
• InjuryMar 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE DOING A REPAIR FOLLOWING THE DELIVERY, THE NEEDLE BROKE. THE DOCTOR WAS SUTURING WHEN SHE NOTICED HALF OF THE NEEDLE HAD BROKEN OFF. THE DOCTOR COULDN¿T FIND IT IN THE PATIENT AND TOOK HER BACK TO OUR OR FOR BETTER VISUALIZATION. AN XRAY WAS DONE AND SHOWED THAT THE MISSING HALF WAS STILL IN THE PATIENT. THE PATIENT WAS TAKEN TO THE MAIN OR WHERE THE ON-CALL UROLOGIST WAS CALLED TO HELP. THE DOCTORS WERE STILL UNABLE TO LOCATE AND RETRIEVE THE MISSING HALF OF THE BROKEN NEEDLE. THIS RESULTED IN PATIENT HAVING PROLONGED HOSPITALIZATION, INTERVENTION AND TEMPORARY HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 13789744 ↗
• InjuryJun 24, 2021Break; Migration; Break; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HAND PROCEDURE WITH SKIN GRAFT FROM UPPER INNER ARM ON (B)(6) 2019 AND THE SUTURE WAS USED ON INSIDE UPPER RIGHT ARM/BICEPS, WHICH WAS A DONOR SITE FOR SKIN GRAFT. THE PATIENT WAS NOT PRETESTED FOR ANY SUTURE MATERIAL REACTIONS. IT WAS REPORTED THAT A FEW DAYS POST OP THE UPPER ARM INCISION STARTED POPPING OPEN IN AREAS. THE PATIENT EXPERIENCED DEHISCENCE. THIS CONTINUED TILL WITH REPETITIVE DAILY TREATMENTS THEY CLOSED. IT WAS DECIDED THEN THAT THE PATIENT HAD A REACTION TO THE SUTURE. ITCHING AND REDNESS WERE OBSERVED ON (B)(6) 2019 WHEN THE BANDAGE FROM SURGERY WAS REMOVED. ON (B)(6) 2019 THE SEVERE ITCHING AND REDNESS WERE NOTICED. SURGEON REMOVED A FEW INTERNAL STITCHES AS SOON AS HEALING WAS NOTED BUT THEY POPPED UP TO THE SKIN SURFACE AND HE CLIPPED THEM. STITCHES WOULD POP OPEN AS THE REACTION WENT ON AND STITCH LINE DEHISCED. TOPICAL OINTMENT SUCH AS TRIAMCINOLONE ACETONIDE CREAM 0.1% 15G WITH CLOBETASOL PROPIONATE CREAM 0.05% 30G WAS GIVEN. THE DAILY TREATMENTS WERE CHANGING TELFA PADS AND PLACING XEROFORM, PETROLEUM JELLY MULTIPLE TIMES A DAY AND STERI STRIPS TO TRY TO HELP KEEP SKIN TOGETHER AS IT DEHISCED. THE PATIENT ALSO E

  Patient problems: Erythema; Itching Sensation; Local Reaction; Pain; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 12063665 ↗