Coated VICRYL J341HRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705031039056), received between Aug 29, 2019 and Aug 11, 2025 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN TWO UPON THE CLOSURE PROCESS AND PART OF NEEDLE WAS LOST IN ABDOMEN. THE SURGERY DELAYED/PAUSED TO SEARCH FOR THE NEEDLE. INITIALLY, THE SURGEON WAS UNABLE TO VISUAL OR LOCATE BROKEN NEEDLE TIP. THE ABDOMEN WAS TEMPORARILY CLOSED AND IMAGINING WAS COMPLETED WHICH CONFIRMED THAT THE NEEDLE WAS STILL IN THE ABDOMEN. THE INCISION WAS REOPENED. THE TEAM ATTEMPTED TO USE A MAGNET TO DRAW THE BROKEN SHARP TIP OUT. EVENTUALLY, THE SURGEON WAS ABLE TO BRING IT TO VISUAL FIELD AND THE NEEDLE PIECE WAS REMOVED. THE PATIENT HAD TO BE CONVERTED TO A GENERAL ANESTHETIC FOR THE REMAINDER OF PROCEDURE. THE OR LENGTH WAS EXTENDED BY 2 HOURS TO LOCATE AND RETRIEVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22772100 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING OR CASE, THE SUTURE NEEDLE SNAPPED IN HALF AND THE BROKEN NEEDLE TIP LANDED IN THE OPEN ABDOMEN OF THE PATIENT. SURGICAL TEAM COULD NOT LOCATE IMMEDIATELY, X-RAY REQUIRED AND BROKEN NEEDLE TIP CONFIRMED WITH IMAGING TO BE IN THE ABDOMEN. INCISION REOPENED AND TIP EVENTUALLY RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576815 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT POST-OP MULTIPLE ANIMAL PROCEDURES THAT THE SUTURE WOULD START TO DISSOLVE WITH IN DAYS CREATING WOUND DEHISCE. PATIENTS CURRENTLY DOING WELL.

  Patient problems: Wound Dehiscence

  MAUDE report 21754618 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED A ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, PROCEDURE THE SUTURE WOULD START TO DISSOLVE WITH IN DAYS CREATING WOUND DEHISCE. ANIMAL CURRENTLY DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21753329 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT BROKE MID-SUTURE, NOT AT ATTACHMENT TO THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751609 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT BROKE MID-SUTURE, NOT AT ATTACHMENT TO THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751608 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY & LEFT OOPHORECTOMY SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE SUTURE NEEDLE APPEARED TO BE BROKEN OFF. FLAT-PLATE X-RAY OF ABDOMEN COMPLETED, IMPACT OF INCIDENT: MINOR DELAY OF PROCEDURE. INVASIVE PROCEDURE? NOT PROVIDED OR NOT APPLICABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768767 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. IT IS UNCLEAR AT WHAT POINT, BUT THE SURGEON FOUND SOMETHING GLOWING INSIDE THE BODY AND WHEN THE SURGEON REMOVED IT, IT WAS A NEEDLE TIP. IT IS UNKNOWN WHEN EXACTLY DURING THE SURGERY, BUT IT SEEMED THAT THE NEEDLE WAS BROKEN. NO NEEDLE WAS LEFT INSIDE THE BODY. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004925 ↗
• MalfunctionJul 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE IS SEPARATING FROM SUTURE WHEN PULLING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413867 ↗
• MalfunctionJul 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE IS SEPARATING FROM SUTURE WHEN PULLING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413863 ↗
• MalfunctionApr 19, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WITH USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773226 ↗
• MalfunctionDec 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO GET THE NEEDLE OUT OF THE TROCAR, IT GOT CAUGHT AND THE NEEDLE GOT STUCK IN THE TROCAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988843 ↗
• MalfunctionSep 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO READ THE QR CODE ON THE SUTURE PACKAGING. IT WAS NOTED THAT THE PROBLEM WAS NOT WITH THE READER, BUT IN THE QUALITY OF PRINTING THE QR CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499667 ↗
• MalfunctionAug 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264541 ↗
• MalfunctionAug 10, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THAT DURING ANIMAL SURGERY MULTIPLE SUTURES WERE FRAYING. A NEW BOX WAS OPENED, AND THE CASE COMPLETED WITHOUT ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198447 ↗
• MalfunctionJul 14, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019937 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. THIS HAPPENED IN SEVERAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987539 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. THIS HAPPENED IN SEVERAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987502 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. THIS HAPPENED IN SEVERAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987490 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. THIS HAPPENED IN SEVERAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987486 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. THIS HAPPENED IN SEVERAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987436 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL OPEN HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. TWO UNITS WOULD BE USED, BUT WHEN THESE BROKE ANOTHER TWO WERE USED, AND THE SAME THING HAPPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090711 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL OPEN HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. TWO UNITS WOULD BE USED, BUT WHEN THESE BROKE ANOTHER TWO WERE USED, AND THE SAME THING HAPPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090701 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL OPEN HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. TWO UNITS WOULD BE USED, BUT WHEN THESE BROKE ANOTHER TWO WERE USED, AND THE SAME THING HAPPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090681 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL OPEN HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. TWO UNITS WOULD BE USED, BUT WHEN THESE BROKE ANOTHER TWO WERE USED, AND THE SAME THING HAPPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090661 ↗