Coated VICRYL VCP339H (UDI 10705031052475)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031052475), received between Oct 25, 2019 and Jul 2, 2026 — classified as 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PARTIAL NEPHRECTOMY ON (B)(6) 2017 AND SUTURE WAS USED. DURING THE PROCEDURE, A SURGICAL NEEDLE WAS INADVERTENTLY RETAINED. THE PATIENT HAD A TOMOGRAPHY/CT SCANS PERFORMED IN (B)(6) 2018 AND (B)(6) 2020 WHICH CONFIRMED THE PRESENCE OF A CURVED METAL STRUCTURE (HALF-MOON SHAPE), RADIOPAQUE, WITH ABOUT 2.5 CM IN THE LARGEST AXIS, HOUSED NEAR THE LOWER POLE OF THE RIGHT KIDNEY AND ENCAPSULATED BY FIBROSIS, WITHOUT MOBILITY. FROM THE LIST OF MATERIALS USED IN THE SURGERY, THE NEEDLE CORRESPONDS, WITH A HIGH PROBABILITY, TO THE CT-1 NEEDLE. THE PATIENT CURRENTLY NEEDS TO CHECK IF SHE CAN HAVE AN MRI SCAN SAFELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25689950 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE WOUND OPENED INTERNALLY AFTER HAVING SUTURED MORE THAN 14-15 DAYS AFTER SUTURING IT HAS BEEN EVIDENCED AFTER THIS TIME THE SUTURES ARE EXPELLED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24625698 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY FOR A BROKEN COLLARBONE ON (B)(6) 2025 AND SUTURE WAS USED. THE ACCIDENCE AND INITIAL TREATMENT WAS ON (B)(6) 2025. TIMELINE OF EVENTS: ON (B)(6): SURGERY FOR BROKEN COLLARBONE, ON (B)(6): DISCHARGE, ON (B)(6): SUTURE REMOVAL, ON (B)(6): TWO 3MM WEEPING SCABS REMOVED, ON (B)(6): WOUNDS ALMOST CLOSED, PROTECTIVE DRESSING APPLIED, ON (B)(6): WOUND CLOSED. IT WAS REPORTED THAT ONE ADDITIONAL CHECK-UP WAS PROVIDED, AS THREE POSTOPERATIVE CHECK-UPS ARE SCHEDULED AND JUSTIFIED. FOURTH VISIT WAS DUE TO WOUND COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction

  MAUDE report 24044572 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE THAT UNCOUPLES FROM THE NEEDLE IN THE FIRST STEP THROUGH THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512468 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE BEING USED AND THE THREAD NEEDLE WAS DISASSEMBLED INTO 3 SUTURES OF THE SAME GAUGE AND REFERENCE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506289 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE BEING USED AND THE THREAD NEEDLE WAS DISASSEMBLED INTO 3 SUTURES OF THE SAME GAUGE AND REFERENCE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506127 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE BEING USED AND THE THREAD NEEDLE WAS DISASSEMBLED INTO 3 SUTURES OF THE SAME GAUGE AND REFERENCE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506125 ↗
• InjuryJan 10, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, WITHIN HOURS OF THE SUTURE BEING IMPLANTED IN THE PATIENT, THE SUTURE CAME UNDONE, ITS STRENGTH WAS LOST. THE SUTURE BEGAN TO UNRAVEL. THE PATIENT UNDERWENT REOPERATION TO REPAIR THE TISSUE DEHISCENCE AND ANOTHER SUTURE WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21123143 ↗
• MalfunctionSep 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE THREAD COMES OUT OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127753 ↗
• MalfunctionSep 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE THREAD COMES OUT OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127741 ↗
• MalfunctionAug 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. IT DISASSEMBLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048386 ↗
• MalfunctionAug 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. IT DISASSEMBLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046801 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. IT DISASSEMBLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039322 ↗
• MalfunctionMay 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY, THE VICRYL SUTURE BECAME LOOSE AND CAUSED REPROCESSING, REQUIRING NEW SUTURES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267159 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, JUST AFTER MAKING THE FIRST FIXATION POINT, IN THE FIRST PASS TO CONTINUE THE CLOSURE, THE NEEDLE WAS SEPARATED FROM THE THREAD. THEREFORE, ANOTHER SUTURE ENVELOPE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921550 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE BODY PART WHEN THE 1ST STITCH WAS APPLIED AT THE TIME OF WOUND CLOSURE. THEN, THE SURGEON TRIED TO USE (B)(6), BUT THE NEEDLE WAS ALSO BROKEN AT THE BODY PART AT THE 1ST STITCH. THEREFORE, ANOTHER SURGEON USED ANOTHER (B)(6) BUT THE NEEDLE WAS BENT SO ANOTHER (B)(6) WAS USED AND THE WOUND WAS SUTURED WITHOUT ANY PROBLEMS THIS TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610500 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN PULLING ON THE PRODUCT TO BRING THE WOUND TOGETHER. THE PRODUCT WAS USED ON UTERINE SEROSA. MYOMA ENUCLEATION WAS ENUCLEATED FROM TWO LOCATIONS, AND THE SUTURE BROKE AFTER ABOUT THE 3RD STITCH IN BOTH CASES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337237 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON 20/11/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN PULLING ON THE PRODUCT TO BRING THE WOUND TOGETHER. THE PRODUCT WAS USED ON UTERINE SEROSA. MYOMA ENUCLEATION WAS ENUCLEATED FROM TWO LOCATIONS, AND THE SUTURE BROKE AFTER ABOUT THE 3RD STITCH IN BOTH CASES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337235 ↗
• MalfunctionOct 20, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974679 ↗
• MalfunctionOct 20, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974677 ↗
• MalfunctionOct 20, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974676 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT DUE TO POOR STRENGTH, IT BROKE DURING SURGERY. THE SUTURE WITH LOW TENSILE STRENGTH, ONCE OPENED, IT IS PASSED TO THE POINT IN THE SUBCUTANEOUS CELLULAR TISSUE AND WHEN KNOTTED, IT BREAKS IMMEDIATELY. IT WAS TRIED AGAIN AND IT BREAKS AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862619 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT DUE TO POOR STRENGTH, IT BROKE DURING SURGERY. THE SUTURE WITH LOW TENSILE STRENGTH, ONCE OPENED, IT IS PASSED TO THE POINT IN THE SUBCUTANEOUS CELLULAR TISSUE AND WHEN KNOTTED, IT BREAKS IMMEDIATELY. IT WAS TRIED AGAIN AND IT BREAKS AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862618 ↗
• InjuryMar 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND THE FASCIA WAS CONTINUOUSLY SUTURED WITH BARBED SUTURE. THE PATIENT WAS (B)(6) FOR CORONA OMICRON. THE WOUND WAS OPENED 8 TO 10 DAYS AFTER SURGERY. WHEN IT WAS CHECKED, THE SUTURE SITE OF THE UTERINE WOUND WAS NOT BROKEN, BUT THERE WAS NO SUTURE IN THE FASCIA MUSCLE LAYER AND DERMAL WOUND, AND THE WOUND WAS DEHISCENT. ONLY THE FIRST AND LAST LIGATION POINTS REMAINED, BUT THE MIDDLE SUTURE WAS COMPLETELY DISAPPEARED. THE SIZE OF THE INCISION WAS APPROXIMATELY 15 CM. RE-SUTURING WAS PERFORMED. THE ONLY DIFFERENCE FROM THE PAST WAS THAT AN ANTIBODY COCKTAIL, RONAPREVE, WAS ADMINISTERED BECAUSE THE PATIENT WAS A CORONA PATIENT. THE PATIENT HAS BEEN DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Wound Dehiscence

  MAUDE report 13826803 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIO PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING SURGERY THE SUTURE FAILED. THE SUTURE WAS CUT DURING USE. THE SUTURE REPLACED WHEN THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408711 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and