Coated VICRYL J347HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031039131), received between Mar 29, 2019 and Nov 7, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE: ONE ATRAUMATIC TIP GOT SPLIT FROM SUTURE NEEDLE INTRAOPERATIVELY, TIP GOT DISLODGE WHEN THE DEVICE WAS NOT INSIDE THE PATIENT, TIP APPROXIMATED TO BE 0.5CM. NO PATIENT HARM REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498906 ↗
• MalfunctionMay 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE PREPARATION OF SURGICAL SUPPLIES FOR A STAT LOW TRANSVERSE CESAREAN SECTION LAST (B)(6) 2025, THE CIRCULATING NURSE WAS ASSISTING SCRUB NURSE IN ORGANIZING THE NECESSARY INSTRUMENTS AND SUTURES. THEY OPENED A STERILE PACK CONTAINING VICRYL 1 ATR SUTURE. UPON INSPECTION, THEY BOTH OBSERVED THAT THE NEEDLE OF THE SUTURE WAS VISIBLY RUSTY. THEY IMMEDIATELY REPLACED THE AFFECTED SUTURE WITH A NEW STERILE VICRYL 1 ATR SUTURE FROM THE AVAILABLE STOCK. THE RUSTY VICRYL 1 ATR WAS RETAINED AND PLACED IN ISOLATION AND ENDORSED TO THE HEAD OF CSR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989663 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AN ISSUE WITH THE SUTURE SNAPPING WHEN TRYING TO TIE OFF OCCURRED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260292 ↗
• MalfunctionAug 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE C-SECTION PROCEDURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470739 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A VICRYL 1 SUTURE THAT BROKE THE TIP OF THE NEEDLE WHILE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991570 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE MATERIAL KEEPS BREAKING WHEN APPROXIMATING THE TISSUES. SURGEON BROKE 3 STRANDS BEFORE ASKING TO REMOVE LOT # AND USED OTHER SAME SUTURE MATERIAL AND SIZE FROM A DIFFERENT LOT AND SUTURE PERFORMED AS EXPECTED WITHOUT BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802011 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE MATERIAL KEEPS BREAKING WHEN APPROXIMATING THE TISSUES. SURGEON BROKE 3 STRANDS BEFORE ASKING TO REMOVE LOT # AND USED OTHER SAME SUTURE MATERIAL AND SIZE FROM A DIFFERENT LOT AND SUTURE PERFORMED AS EXPECTED WITHOUT BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802006 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED, THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023. AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE MATERIAL KEEPS BREAKING WHEN APPROXIMATING THE TISSUES. SURGEON BROKE 3 STRANDS BEFORE ASKING TO REMOVE, LOT # AND USED OTHER SAME SUTURE MATERIAL AND SIZE FROM A DIFFERENT LOT AND SUTURE PERFORMED AS EXPECTED WITHOUT BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802005 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BROKE FROM 2 DEVICES WHEN KNOTTING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760350 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BROKE FROM 2 DEVICES WHEN KNOTTING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760208 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797579 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. AT THE TIME OF SUTURING THE FASCIA OF THE RECTUS MUSCLES IN ITS FINAL PHASE, THE NEEDLE WAS FRAGMENTED INTO TWO PIECES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915320 ↗
• InjuryMar 29, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE APPROXIMATELY TWO-THIRDS OF THE WAY DOWN THE NEEDLE SHAFT. THE SUTURE COULD NOT BE LOCATED. THE PATIENT WAS X-RAYED POST-PROCEDURE AND THE NEEDLE COULD BE SEEN. THE SURGEON SENT THE PATIENT TO THE NEAREST TERTIARY HOSPITAL WHERE THE SUTURE NEEDLE WAS LOCATED AND REMOVED UNDER IMAGE INTENSIFIER AS THE HOSPITAL WHERE THE INCIDENT HAPPENED DOES NOT HAVE AN IMAGE INTENSIFIER. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 8463845 ↗