Coated VICRYL VCP347H (UDI 10705031052598)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031052598), received between Feb 1, 2013 and Jan 21, 2026 — classified as 7 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Material Separation” (24 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE IS DISASSEMBLED FROM THE SUTURE IN INTRASURGICAL USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132568 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE DETACHES FROM THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072547 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE DETACHES FROM THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072253 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE DETACHES FROM THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072188 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ABDOMINAL HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, AT THE TIME OF KNOTTING THE SUTURE STRAND VICRYL, GYNECOLOGICAL SURGERY VIA OPEN IS BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436703 ↗
• InjuryApr 21, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THEY REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED IN THE DOME OF THE PATIENT. THE PATIENT RETURNED AFTER 14 DAYS WITH A HEMATOMA AND AQUEOUS FLUID COMING OUT OF THE VAGINA, AND WHEN CHECKING THE DR DETECTS THAT THERE WERE NO REMNANTS OF THE SUTURE AND THE PATIENT HAD A DEHISCENCE IN THE DOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Hematoma; Wound Dehiscence

  MAUDE report 21873577 ↗
• InjuryApr 21, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THEY REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED IN THE DOME OF THE PATIENT. THE PATIENT RETURNED AFTER 14 DAYS WITH A HEMATOMA AND AQUEOUS FLUID COMING OUT OF THE VAGINA, AND WHEN CHECKING THE DR DETECTS THAT THERE WERE NO REMNANTS OF THE SUTURE AND THE PATIENT HAD A DEHISCENCE IN THE DOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Hematoma; Wound Dehiscence

  MAUDE report 21873558 ↗
• InjuryApr 21, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THEY REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED IN THE DOME OF THE PATIENT. THE PATIENT RETURNED AFTER 14 DAYS WITH A HEMATOMA AND AQUEOUS FLUID COMING OUT OF THE VAGINA, AND WHEN CHECKING THE DR DETECTS THAT THERE WERE NO REMNANTS OF THE SUTURE AND THE PATIENT HAD A DEHISCENCE IN THE DOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Hematoma; Wound Dehiscence

  MAUDE report 21873553 ↗
• InjuryDec 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS PERFORMED AGAIN FOR DAMAGE TO THE FIRST ONE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21047354 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. AT THE TIME OF CLOSING THE SURGICAL INCISION, THE SUTURE 1/0 BREAKS REPEATEDLY WITHOUT EXERTING FORCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677725 ↗
• MalfunctionAug 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE BLADDER, THE NEEDLE THREAD BECOMES DISASSEMBLED AND IS LOST IN THE PATIENT'S ABDOMINAL CAVITY, REQUIRING THE USE OF AN IMAGE INTENSIFIER TO LOCATE IT. ONCE THE NEEDLE IS FOUND, IT IS REMOVED AND THE PROCEDURE CONTINUES. A NEW SUTURE IS THEN PASSED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955587 ↗
• MalfunctionJun 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THREAD CAME OUT OF THE NEEDLE IN THE MIDDLE OF CLOSING THE FABRIC. THE SUTURE BROKE EASILY WHEN TENSION WAS APPLIED, SPECIFICALLY AT THE JUNCTION WITH THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559989 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN ROBOTIC PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. WHILE SUTURING, THE NEEDLE BROKE OFF DURING THE LAST PASS. THEY WERE ABLE TO RETRIEVE THE NEEDLE AND COMPLETE THE REST OF THE PROCEDURE WITHOUT PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299693 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DISASSEMBLED FROM THE NEEDLE, CAUSING A FIVE-MINUTE DELAY IN SURGERY AND RISK TO THE PERSONNEL INVOLVED. A NEW SUTURE WAS PASSED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278490 ↗
• MalfunctionApr 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLOSTOMY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE UNASSEMBLED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101283 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2024, AND SUTURE WAS USED. DURING SURGERY, WHEN PASSING THE STITCH AND PULLING TO CONTINUE WITH THE NEXT STITCH, THE NEEDLE THREAD IS DISASSEMBLED, A NEW SUTURE IS PASSED TO CONTINUE THE PROCEDURE. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO OTHER INTERVENTION WAS REQUIRED. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858588 ↗
• MalfunctionFeb 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO VICRYL 1 SUTURES ARE USED (LOT: AU2995, WITH EXPIRATION DATE 2028-02) WHICH WHEN STARTING THE SUTURE, THE THREAD COMES LOOSE FROM THE NEEDLE, LEAVING THE SUTURE COMPLETE AND TOTALLY USELESS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699811 ↗
• MalfunctionFeb 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO VICRYL 1 SUTURES ARE USED (LOT: AU2995, WITH EXPIRATION DATE 2028-02) WHICH WHEN STARTING THE SUTURE, THE THREAD COMES LOOSE FROM THE NEEDLE, LEAVING THE SUTURE COMPLETE AND TOTALLY USELESS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699810 ↗
• InjuryFeb 1, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GALLBLADDER REMOVAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, ALL OF THE OTHER SUTURE LINES HAD HEALED ASIDE FROM THE BELLYBUTTON. THE SUTURE WAS NOT HEALING AND WOULD NOT SCAB. THE PATIENT HAD SILVER PUT ON THE SUTURING TO HELP STERILIZE IT AND CAUTERIZE IT ON (B)(6) 2024. IT WAS CALLED IT A SPLIT STITCH. THE SUTURE WOULD NOT DISSOLVE. IT WAS STATED THAT POSSIBLE OUTCOMES FOR PATIENT INCLUDE HAVING THE SUTURE TAKEN OUT AND RE-SUTURED WITH A DIFFERENT TYPE. IT IS UNCLEAR IF THE PATIENT IS HAVING A REACTION/ALLOGENIC REACTION TO THE SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 18625320 ↗
• InjuryDec 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC REMOVAL OF RIGHT OVARY, RIGHT OOPHORECTOMY, AND DRAINAGE OF LEFT OVARIAN CYST PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, ON THE LAST STITCH OVER ON THE LEFT SIDE, THE NEEDLE BROKE APPROXIMATELY THREE FOURTHS TO ITS CURVATURE. THERE WAS A FULL CENTIMETER PLUS NEEDLE FRAGMENT NOW IN THE SUBCUTANEOUS TISSUE. THE SURGEON SEARCHED AND PALPATED AND THE DOCTOR COULD NOT FIND IT. CONSEQUENTLY X-RAY WAS CALLED AND THEY WERE ABLE TO PINPOINT THE CURVED NEEDLE IN THE SUBCUTANEOUS TISSUE JUST LATERAL TO THE INCISION. WITH THE HELP OF X-RAY, THE DOCTOR WAS ABLE TO CUT DOWN ON THIS AREA AND FIND THE NEEDLE AND RETRIEVE IT. WITH THE CORRECT NEEDLE COUNTY NOW IN PLACE, THE DOCTOR RECLOSED THE FASCIA WITH ANOTHER SUTURE. AN ADDITIONAL X-RAY WAS PERFORMED IN THE RECOVERY ROOM TO CONFIRM THAT NEEDLE WAS FULL REMOVED. THERE WAS NO HARM TO PATIENT. THE PATIENT IS RECOVERING WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18245767 ↗
• MalfunctionNov 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE VICRYL 1 CT-1 HAS PRESENTED CHALLENGES SINCE THE SUTURE IS DISASSEMBLING OF THE NEEDLE THREAD, THIS EVENT OCCURRED TWICE WITH DR. THE DOCTOR INFORMS THAT OTHER SURGICAL INSTRUMENTALISTS HAVE HAD THE SAME ISSUE WITH THIS PRODUCT. IT WAS CONFIRMED THAT THE ISSUE DID NOT CAUSED ANY HARM TO THE PATIENTS. TO RESOLVE THESE ISSUES THEY USED NEW SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145042 ↗
• MalfunctionNov 14, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT HAS PRESENTED CHALLENGES SINCE THE SUTURE IS DISASSEMBLING OF THE NEEDLE THREAD, IT WAS CONFIRMED THAT THE ISSUE DID NOT CAUSE ANY HARM TO THE PATIENT. TO RESOLVE THE ISSUE THEY USED NEW SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18135678 ↗
• MalfunctionNov 14, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT HAS PRESENTED CHALLENGES SINCE THE SUTURE IS DISASSEMBLING OF THE NEEDLE THREAD, IT WAS CONFIRMED THAT THE ISSUE DID NOT CAUSE ANY HARM TO THE PATIENT. TO RESOLVE THE ISSUE THEY USED NEW SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18135660 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT A CESAREAN SECTION PATIENT PRESENTED UTERINE ATONY AND A B-LYNCH PROCEDURE WAS PERFORMED ON (B)(6) 2023. WITH THE USE OF SUTURE. AT THE TIME OF MAKING THE KNOT, THE SUTURE WAS COMPLETELY TORN AND NEW SUTURE WAS REQUESTED. THE B-LYNCH IS PERFORMED AGAIN. AGAIN WHEN THE KNOT IS MADE, THE SUTURE IS TORN. THERE WAS A DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863196 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT A CESAREAN SECTION PATIENT PRESENTED UTERINE ATONY AND A B-LYNCH PROCEDURE WAS PERFORMED ON (B)(6) 2023 WITH THE USE OF SUTURE. AT THE TIME OF MAKING THE KNOT, THE SUTURE WAS COMPLETELY TORN AND NEW SUTURE WAS REQUESTED. THE B-LYNCH IS PERFORMED AGAIN. AGAIN WHEN THE KNOT IS MADE, THE SUTURE IS TORN. THERE WAS A DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863194 ↗

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