Coated VICRYL J978HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031043800), received between Oct 28, 2019 and Nov 18, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THAT ONE SUTURE SNAPPED AT THE TIME OF SURGERY. SHE STATES THAT THE DOCTOR DID NOT APPLY TOO MUCH PRESSURE AND IT BROKE. THERE WAS NO PATIENT HARMED. THEY OPENED A NEW SUTURE AND THAT ONE WORKED JUST FINE. SHE HAS THE BROKEN SUTURE IN A BAG AND WOULD TO GET A SHIPPER KIT TO RETURN IT FOR INVESTIGATION. DEVICE WAS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586734 ↗
• MalfunctionJan 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON 19/12/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES POPPED OFF DURING A C-SECTION CASE. THEY WERE ABLE TO COMPLETE THE CASE WITH NO PATIENT HARM. DEVICES ARE AVAILABLE TO BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501911 ↗
• 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. IN THE OR THE NEEDLE AND SUTURE CAME APART AS THE MD WAS CLOSING, THE MD STILL HAD THE NEEDLE ON THE NEEDLE DRIVER, THEY HAD SEPARATED. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358201 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY LOW TRANSVERSE CESAREAN DELIVERY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE NEEDLE TIP WAS BROKEN OFF AFTER THE SECOND STITCH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165263 ↗
• MalfunctionJun 11, 2021Break

  NEEDLE TIP OF ETHICON COATED VICRYL UNDYED BRAIDED (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE LOST DURING CESAREAN SECTION. X-RAY OF ABDOMEN AND PELVIS WERE NEGATIVE FOR ANY RADIOPAQUE FOREIGN BODY. THE FIRST STITCH OF 0 VICRYL CTX WAS COMPLETED AND THEN IT WAS NOTED THAT THE NEEDLE TIP WAS BROKEN OFF AFTER THE SECOND STITCH. IT IS UNKNOWN AS TO WHETHER OR NOT THE FIRST STITCH HAD A BROKEN NEEDLE TIP. THE REMAINDER OF THE CLOSURE WAS CONTINUED AFTER EXAMINING THE SURGICAL FIELD AND FINDING NO EVIDENCE OF THE NEEDLE TIP. THE UTERUS WAS CLOSED WITH A RUNNING UNLOCKED SUTURE. IT WAS THEN IMBRICATED WITH 0 MONOCRYL IN A HORIZONTAL IMBRICATING SUTURE AND THE BLADDER FLAP WAS CLOSED AFTER HEMOSTASIS WAS ASSURED USING 2-0 PDS IN A RUNNING UNLOCKED SUTURE. THE FIELD WAS AGAIN EXAMINED AND NO NEEDLE TIP WAS ENCOUNTERED. HEMOSTASIS WAS ASSURED ON THE HYSTEROTOMY AND THE PERITONEUM WAS CLOSED USING 3-0 VICRYL IN A RUNNING UNLOCKED SUTURE. AT THIS POINT, X-RAY WAS CALLED AND MULTIPLE X-RAYS WERE TAKEN OF THE PATIENT'S ABDOMEN. THERE WERE NO NEEDLE TIPS NOTED ON THE X-RAYS PER THE RADIOLOGIST.

  Patient problems: Insufficient Information

  MAUDE report 11982537 ↗
• InjuryOct 28, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE CAME OFF AND FELL INTO THE PATIENT. X-RAY CONFIRMED THE FRAGMENT. AFTER THREE ATTEMPTS TO RETRIEVE THE FRAGMENT THEY COULD NO LONGER LOCATE IT AND HAD TO ABORT. THE PATIENT'S UTERUS WAS OUT OF CAVITY FOR FIVE HOURS. THE PATIENT APPEARS TO BE FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Device Embedded In Tissue or Plaque; Not Applicable

  MAUDE report 9245846 ↗