Coated VICRYL J345HRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031039094), received between Oct 2, 2018 and Aug 24, 2026 — classified as 11 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (20 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410611 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE AND SUTURE WAS DETACHED WHILE SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818421 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790635 ↗
• MalfunctionJul 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING CESAREAN SECTION SURGERY, A THREAD NEEDLE WAS DETACHED IN THE TISSUE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559745 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER SEGMENT CESAREAN SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHILE SUTURING THE FASCIA. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925451 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THREE LOWER UTERINE CESAREAN SECTIONS+LEFT OVARIAN CYSTECTOMY PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. AT 09:20, A PREGNANT WOMAN WITH A HISTORY OF CESAREAN SECTION WAS HOSPITALIZED FOR PLANNED DELIVERY. SURGERY ON THE FOLLOWING DAY FROM 10:38 TO 12:16. DURING THE THREE LOWER UTERINE CESAREAN SECTIONS+LEFT OVARIAN CYSTECTOMY SURGERY, THE SUTURE WAS BROKEN DURING THE SUTURING OF THE PERITONEUM, CAUSING BLEEDING AT THE SUTURE SITE. THE BLEEDING STOPPED AFTER THE SUTURING WAS REPEATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21610048 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS PULLED APART WHEN IT WAS USED TO SEW THE PERITONEUM. CHANGED TO ANOTHER ONE TO CONTINUE SUTURING. THIS INCREASED THE PATIENT'S MEDICAL EXPENSES AND INCREASED THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 21587532 ↗
• MalfunctionJan 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, NONABSORPTION OF SUTURE POST-OP. THIS CASE IS FROM HEALTH AUTHORITY. THE SUTURE WAS FOUND NOT ABSORBED AND NEEDED TO BE REMOVED AGAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21246194 ↗
• MalfunctionJan 7, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095592 ↗
• MalfunctionDec 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY DURING PASSAGE THROUGH TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE 1 ACTUAL SAMPLE WAS DISCARDED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922267 ↗
• MalfunctionOct 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY AT 3:00 PM. AFTER THE DELIVERY OF THE FETUS, THE DOCTOR SUTURED IT IN TWO LAYERS WITH SUTURE. BEFORE SUTURING, THE CUTTING EDGE, ESPECIALLY THE CORNERS ON BOTH SIDES, WAS CHECKED FOR TEARING AND ELONGATION. THE FIRST LAYER IS CONTINUOUSLY SUTURED WITHOUT PENETRATING THE ENDOMETRIAL LAYER. THE SECOND LAYER OF CONTINUOUS MATTRESS EMBEDDING SUTURE WAS PERFORMED WITH A NEEDLE INSERTION DEPTH OF 2/3 OF THE CUTTING EDGE. WHEN SUTURING THE SECOND LAYER OF TISSUE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE UTERINE WOUND WAS STILL BLEEDING. THE DOCTOR IMMEDIATELY REMOVED THE SUTURE, REPLACED IT WITH A NEW ONE, AND SUTURED THE PATIENT AGAIN. THE HEMOSTASIS WAS SUCCESSFUL AND THE SURGERY WENT SMOOTHLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413326 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT FULL-TERM PREGNANCY ON (B)(6) 2024 AND SUTURE WAS USED. AT 9:30, THE PATIENT UNDERWENT SURGERY UNDER SPINAL ANESTHESIA AND WAS SUCCESSFULLY DELIVERED. THE DOCTOR USED SUTURE TO SUTURE THE SKIN, BUT THE SUTURE BROKE. THE DOCTOR CHECKED THAT THE SKIN NEEDLE WAS INTACT. IMMEDIATELY REPLACE THE SKIN NEEDLE WITH A NEW ONE FOR SUTURING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296486 ↗
• InjuryApr 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2024 AND SUTURE WAS USED. THE PARTURIENT DELIVERED A MATURE LIVE FEMALE INFANT THROUGH A PERINEAL INCISION. THE DOCTOR SUTURED THE PERINEAL INCISION. FOUND POOR ABSORPTION AND HEALING OF THE SUTURE, REMOVED THE SUTURE, DISINFECTED IT, AND SUTURED IT AGAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 19121389 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ENDOSCOPIC OVARIAN LESION RESECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AT 10:30 AM, DURING THE USE OF SUTURE FOR OVARIAN RECONSTRUCTION, THE SUTURE BROKE. THE DOCTOR CHECKED THAT THERE WAS NO OBVIOUS DAMAGE AT THE SUTURED INCISION. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373972 ↗
• MalfunctionDec 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. 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 18366763 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION PROCEDURE ON 22 OCT 2023 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGERY DUE TO FULL TERM PREGNANCY, AND THE DELIVERY WAS SMOOTH. DURING THE PROCEDURE, THE SUTURE BROKE WHILE THE DOCTOR WAS SUTURING THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300785 ↗
• MalfunctionNov 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132178 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED WHEN SURGEON USED SUTURE TO SUTURE THE PATIENT'S WOUND. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749659 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR A PERINEAL LACERATION ON (B)(6) 2023 AND SUTURE WAS USED. ON THE 6TH DAY AFTER PERINEAL LACERATION SURGERY, THE PATIENT COMPLAINED OF PERINEAL PAIN AND DEHISCENCE. THE PATIENT HAD INFLAMMATION. THE PATIENT'S VULVAR WOUND WAS RED, SWOLLEN, TINGLING, WITH EXPOSED SUTURE, AND DID NOT HEAL. THE DOCTOR CUT OFF THE SURFACE SUTURE AND CLEANED IT WITH POTASSIUM PERMANGANATE SOLUTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Itching Sensation; Pain; Pocket Erosion; Skin Inflammation/ Irritation; Swelling/ Edema; Wound Dehiscence

  MAUDE report 17405818 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 DUE TO UMBILICAL CORD PROLAPSE AND OBSTRUCTIVE DELIVERY AND SUTURE WAS USED ON THE SURGICAL INCISION. ON THE 6TH DAY AFTER THE SURGERY, THE PATIENT'S SURGICAL INCISION APPEARED EXUDATION. THE PATIENT HAD POOR WOUND HEALING AND WOUND SECRETION. THE DOCTOR GAVE THE EXUDATE BACTERIA NEGATIVE CULTURE. AFTER THE SUTURE WAS REMOVED, THE SURGICAL INCISION DID NOT HEAL WELL. THE PATIENT WAS GIVEN DEBRIDEMENT AND DRESSING CHANGE, AND STERILE GAUZE WAS GIVEN TO COVER THE SURGICAL INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 17405437 ↗
• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR THE DELIVERY OF THE PATIENT'S SECOND PREGNANCY WITH SUTURING OF PERINEAL LACERATION ON AN UNKNOWN DATE AND SUTURE WAS USED. NINE DAYS AFTER THE SURGERY, THE PATIENT COMPLAINED OF PERINEAL PAIN AND RUPTURE. THE PATIENT'S VULVAR WOUND IS RED, SWOLLEN, STINGING, WITH EXPOSED SUTURE, AND DOES NOT HEAL. THE PATIENT HAD POST OP INFLAMMATION. CUT OFF THE SURFACE SUTURE ACCORDING TO THE DOCTOR'S INSTRUCTIONS AND CLEAN IT WITH POTASSIUM PERMANGANATE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Inflammation; Pain; Pocket Erosion; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17332888 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE PATIENT¿S PERINEUM, THE DOCTOR NOTICED THE TIP OF THE SUTURE APPEARS TO BE MISSING. SHE BELIEVES IT BROKE OFF- AS THE INITIAL RUNNING STITCH WENT IN AS NORMAL, BUT THE FIRST OF HER BACK STITCH WOULD NOT PUNCTURE THE SKIN. NO FURTHER SUTURE WAS DONE WITH THIS ATRAUMATIC NEEDLE. A REPLACEMENT SUTURE WAS GIVEN WHICH WAS THE SAME LOT TO DOCTOR AND IT WAS NOT DEFECTIVE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273893 ↗
• InjuryApr 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL EPISIOTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, ON THE 26TH DAY AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF PERINEAL PAIN AND RUPTURE. THE PATIENT HAD INFLAMMATION. THE PATIENT'S EXTERNAL GENITALIA WOUND WAS RED, SWOLLEN, STINGING, EXUDING, WITH EXPOSED SUTURE, AND DOES NOT HEAL. THE DOCTOR CUT OFF THE SURFACE SUTURE OF THE EXTERNAL GENITALIA, SUTURED IT AGAIN, AND WASHED IT WITH POTASSIUM PERMANGANATE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Inflammation; Pain; Pocket Erosion; Skin Inflammation/ Irritation; Swelling/ Edema; Wound Dehiscence

  MAUDE report 16825994 ↗
• MalfunctionJan 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE DOCTOR USED SUTURE TO SEW THE PATIENT'S WOUND DUE TO PERINEAL LACERATION, AND THE PERINEAL SUTURE WAS SUCCESSFULLY HOSPITALIZED WITHOUT DISCOMFORT. IN THE PUERPERIUM, THERE WAS SUTURE REACTION, THE SUTURE WAS NOT ABSORBED, AND THE WOUND WAS TINGLING, SO THE DOCTOR REMOVED THE SUTURE AND THE PAIN WAS RELIEVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Insufficient Information; Local Reaction; Pocket Erosion

  MAUDE report 16230901 ↗
• MalfunctionDec 29, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT SUFFERED FROM UN-ABSORPTION OF SUTURE, SLIGHT EXUDATION OF ABDOMINAL WOUND, AND SLIGHTLY RED SKIN. TWO DAYS AFTER THE DOCTOR REMOVED THE SUTURE BY HAND, THE PATIENTS WOUND HEALED NATURALLY AND FINALLY TURNED TO WOUND HEALING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Fluid Discharge; Inflammation; Skin Inflammation/ Irritation

  MAUDE report 16068017 ↗