Coated VICRYL J359HRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705031039278), received between Jun 24, 2019 and Sep 24, 2026 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (25 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.

• MalfunctionSep 24, 2026Break

  It was reported that a patient underwent a C-Section procedure on (b)(6)2026 and suture was used. During the surgery, the suture was broken when the uterus was sutured. The surgeon immediately clamped the broken tail end with vascular forceps to prevent uterine bleeding and immediately replaced a new suture for suture. The surgery progressed smoothly. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889846 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY C-SECTION PROCEDURE ON (B)(6) 2026 SUTURE WAS USED. WHILE SUTURE THE UTERUS, TWO SUTURE THREADS USED BROKE INTO TWO AFTER THE KNOT WAS TIED. THEY WERE REPLACE WITH TWO OTHER THREADS, WHICH APPEAR TO HAVE HELD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775869 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY C-SECTION PROCEDURE ON (B)(6) 2026 SUTURE WAS USED. WHILE SUTURE THE UTERUS, TWO SUTURE THREADS USED BROKE INTO TWO AFTER THE KNOT WAS TIED. THEY WERE REPLACE WITH TWO OTHER THREADS, WHICH APPEAR TO HAVE HELD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24759611 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A SURGICAL NURSE (B)(6) REPORTED A QUALITY DEFECT REGARDING THE USE OF A SUTURE. DURING A UTERINE SUTURE FOLLOWING A CESAREAN SECTION USING VICRYL 1, THE THREAD BROKE TWICE. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004830 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A SURGICAL NURSE "IBODE" REPORTED A QUALITY DEFECT REGARDING THE USE OF A SUTURE. DURING A UTERINE SUTURE FOLLOWING A CESAREAN SECTION USING VICRYL 1, THE THREAD BROKE TWICE. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004826 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A SURGICAL NURSE "(B)(6)" REPORTED A QUALITY DEFECT REGARDING THE USE OF A SUTURE. DURING A UTERINE SUTURE FOLLOWING A CESAREAN SECTION USING VICRYL 1, THE THREAD BROKE TWICE. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004269 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A SURGICAL NURSE "IBODE" REPORTED A QUALITY DEFECT REGARDING THE USE OF A SUTURE. DURING A UTERINE SUTURE FOLLOWING A CESAREAN SECTION USING VICRYL 1, THE THREAD BROKE TWICE. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004268 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHILE SUTURING AND PULLING THE SUTURE DURING SURGERY, THE SUTURE BROKE. AS THE WOUND WAS NEARING COMPLETION OF SUTURING AND COULD NOT BE REPLACED, MEDICAL STAFF TIED A KNOT AT THE SITE OF THE BROKEN THREAD TO CONTINUE SUTURING THE WOUND. VERIFY AND REPORT, REQUIRE CLOSE ATTENTION TO THE PATIENT'S RECOVERY IN THE LATER STAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20603954 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT WAS PLACED IN A SUPINE POSITION, DISINFECTED, BANDAGED, AND MADE A TRANSVERSE INCISION IN THE ABDOMEN. THE SKIN AND OTHER TISSUES WERE CUT OPEN, AND THE UTERUS WAS CUT OPEN. A MALE BABY WAS SUCCESSFULLY DELIVERED. THE DOCTOR USED SUTURE TO SUTURE THE INCISION IN THE UTERINE MUSCLE LAYER TO THE MOTHER. WHEN THE KNOT WAS TIED, THE SUTURE SUDDENLY BROKE AND COULD NOT BE SUTURED SMOOTHLY. THEREFORE, THE BROKEN SUTURE WAS IMMEDIATELY REMOVED AND REPLACED WITH NEW SUTURE FOR THE MOTHER TO RE SUTURE AND KNOT. THE SUTURE WENT SMOOTHLY, BUT THE QUALITY ISSUE CAUSED SECONDARY SUTURE INJURY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268306 ↗
• InjuryApr 8, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY DUE TO PREGNANCY COMPLICATED WITH UTERINE SCARS ON (B)(6) 2024 AND SUTURE WAS USED. THE PROCEDURE WENT SMOOTHLY. RECURRENT FEVER OCCURRED ON THE 1ST TO 4TH DAY AFTER SURGERY, WITH A MAXIMUM BODY TEMPERATURE OF 39.5 , ACCOMPANIED BY COUGHING AND SPUTUM PRODUCTION. ON THE 7TH DAY AFTER SURGERY, PALE RED AND PALE YELLOW FLUID EXUDATION WAS OBSERVED ON THE RIGHT SIDE OF THE ABDOMINAL INCISION, SUGGESTING FAT LIQUEFACTION. APPLY MAYINGLONG OINTMENT, RETAIN DRAINAGE STRIPS, AND STRENGTHEN DRESSING CHANGE TREATMENT. ON THE 9TH DAY AFTER SURGERY, THE PATIENT SUDDENLY EXPERIENCED A LARGE AMOUNT OF VAGINAL BLEEDING, WITH CLOTS VISIBLE AND A BLEEDING VOLUME OF 1800ML. CONSIDERING THE POSSIBILITY OF UTERINE INCISION RUPTURE AFTER SURGERY, THE DOCTOR IMMEDIATELY PERFORMED AN OPEN ABDOMINAL EXPLORATION UNDER GENERAL ANESTHESIA. AFTER INCISING THE ABDOMINAL CAVITY DURING THE OPERATION, THE GREATER OMENTUM ENVELOPED THE UTERUS, AND THE ORIGINAL SURGICAL INCISION IN THE LOWER SEGMENT OF THE UTERUS HAD PARTIALLY CRACKED AND WAS BRITTLE. THE DOCTOR CONSIDERED THE UTERINE INCISION INFECTION AND RUPTURE, AND PERFORMED A SUBTOTAL HYSTERECTOMY. POSTOPERATI

  Patient problems: Fever; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Scar Tissue; Unspecified Infection

  MAUDE report 19067333 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE OPERATION, WHEN THE GYNECOLOGIST HAD STARTED TO SUTURE, THE NEEDLE PULLED OFF. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861219 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE OPERATION, WHEN THE GYNECOLOGIST HAD STARTED TO SUTURE, THE NEEDLE PULLED OFF. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861180 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON 1-FEBRUARY-2024. AT 20:2, DURING THE PROCESS OF SUTURING THE UTERINE INCISION, THE DOCTOR EXERTED NORMAL FORCE AND THE SUTURE BROKE. SUTURE RETRACTION. THE INCISION BLEEDING SLIGHTLY INCREASED. TOOK A NEW SUTURE AND URGENTLY RE-SUTURED THE INCISION. CLOSE OBSERVATION OF THE PATIENT'S VITAL SIGNS INDICATED NO OTHER ADVERSE REACTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18797401 ↗
• MalfunctionNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE NEEDLE. THIS ISSUE OCCURRED TWICE (2 DIFFERENT DEVICES) ON THE STITCH OF THE HYSTEROSCOPY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166377 ↗
• MalfunctionNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPY PROCEDURE ON 30/09/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE NEEDLE. THIS ISSUE OCCURRED TWICE (2 DIFFERENT DEVICES) ON THE STITCH OF THE HYSTEROSCOPY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166375 ↗
• MalfunctionOct 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE THREAD DISCONNECT FROM NEEDLE AT SWAGE. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. ANOTHER SUTURE WAS OPENED AFTER THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023443 ↗
• MalfunctionOct 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE THREAD DISCONNECT FROM NEEDLE AT SWAGE. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. ANOTHER SUTURE WAS OPENED AFTER THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023407 ↗
• InjurySep 7, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. TWO YEARS PRIOR, THE PATIENT HAD UNDERGONE A C-SECTION AT A DIFFERENT HOSPITAL. DURING THIS SECOND C-SECTION, IT WAS CONFIRMED THAT A SUTURE WAS STILL THERE, WHICH WAS REMOVED OUT OF SUSPICION. THERE WAS NO EFFECT ON THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701826 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE CAN AWAY FROM SUTURE DURING THE THIRD PASS, AND THIS OCCURRED ON TWO OCCASIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198433 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE CAN AWAY FROM SUTURE DURING THE THIRD PASS, AND THIS OCCURRED ON TWO OCCASIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198405 ↗
• MalfunctionMay 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBTOTAL HYSTERECTOMY PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, CAUSING THE SURGEON TO FAIL THE SUTURE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986775 ↗
• MalfunctionApr 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE UNKNOWN PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE PERITONEUM WAS CLOSED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16810549 ↗
• MalfunctionFeb 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD BROKE OFF THE NEEDLE DURING USE. A NEW SUTURE WAS TAKEN TO RESOLVE THE ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278018 ↗
• MalfunctionFeb 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD BROKE OFF THE NEEDLE DURING USE. A NEW SUTURE WAS TAKEN TO RESOLVE THE ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278017 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE NEAR THE CONNECTION PART BETWEEN NEEDLE AND SUTURE DURING CONTINUOUS SUTURING ON MUSCULAR LAYER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGEON HAS USED THE PRODUCT MANY TIMES AND HE USED THE PRODUCT DURING THE SURGERY AS USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740410 ↗