Coated VICRYL VCP345H (UDI 10705031077805)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031077805), received between Apr 22, 2025 and Sep 21, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Separation

  It was reported that a patient underwent a laparoscopic myomectomy and anterior vaginal wall repair under general anesthesia with endotracheal intubation procedure on (b)(6)2026 and suture was used. This case is from health authority. At 08:30, the patient underwent surgery. After completing the removal of uterine fibroids, the surgeon sutured the uterine incision with suture . During the 10:20 suturing process, the needle and suture separated. After discovering abnormalities, the surgeon immediately stopped the operation, checked the surgical field for seamless sutures and residual needle bodies, replaced with new suture of the same specifications, and continued to complete the uterine incision suturing operation. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841343 ↗
• MalfunctionAug 14, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254697 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. IT WAS REPORTED BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215861 ↗
• MalfunctionMay 12, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WAS FOUR PACKAGE OF PRODUCTS LESS THAN EXPECTED IN THE BOX WHEN JUST OPENED. THERE SHOULD BE THIRTY-SIX PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY THIRTY-TWO PACKAGE OF PRODUCTS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148698 ↗
• MalfunctionApr 28, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026, AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX DURING NORMAL CHECKING. NOT INVOLVED IN ANY SURGERY. THERE SHOULD BE THIRTY-SIX PACKAGES OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY THIRTY-FIVE PACKAGES OF PRODUCTS. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016323 ↗
• MalfunctionApr 28, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) OF 2026, AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX DURING NORMAL CHECKING. NOT INVOLVED IN ANY SURGERY. THERE SHOULD BE THIRTY-SIX PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY THIRTY-FIVE PACKAGE OF PRODUCTS. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016221 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP, THAT THE TIP OF THE SUTURE NEEDLE BROKE DURING A CESAREAN SECTION. NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834489 ↗
• MalfunctionApr 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGEON USED A NEEDLE WITH SUTURE TO SUTURE THE UTERINE INCISION, BUT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR IMMEDIATELY REPLACED THE NEEDLE WITH A NEW ONE FOR SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799120 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598299 ↗
• MalfunctionMar 6, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2026 AND SUTURE WAS USED. AT 09:00, WHILE SUTURING THE UTERINE MYOMETRIUM LAYER, THE NEEDLE HOLDER CLAMPED AT 2/3 OF THE ROUND NEEDLE. WHEN PULLING OUT THE SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE SUDDENLY HAPPENED. AFTER THE INCIDENT, CAREFUL EXAMINATION OF THE SUTURE NEEDLE SHOWED NO OBVIOUS MISSING OR BROKEN PARTS, AND THE SUTURE NEEDLE WAS INTACT. NO REPORTED ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530044 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. ¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273083 ↗
• MalfunctionFeb 5, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS FOUND THAT THERE WERE 3 PACKAGE OF PRODUCTS LESS THAN EXPECTED IN THE BOX DURING NORMAL CHECKING. THERE SHOULD BE 36 PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY 33 PACKAGE OF PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271785 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH 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 24071713 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UTERINE FIBROID SURGERY. ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046665 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UTERINE FIBROID SURGERY .ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046663 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL TOTAL HYSTERECTOMY WITH LEFT ADNEXECTOMY AND RIGHT SALPINGECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY. DURING THE SURGERY, WHILE CONTINUOUSLY SUTURING THE FASCIA LAYER WITH SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED MIDWAY, MAKING IT IMPOSSIBLE TO CONTINUE USING. THE SUTURE WAS REPLACED AND SUTURED AGAIN, WHICH INCREASED THE AMOUNT OF BLEEDING, THE OPERATION TIME, THE RISK OF ANESTHESIA AND THE RISK OF POOR WOUND HEALING. THE PROCEDURE SHOULD BE ABDOMINAL TOTAL HYSTERECTOMY WITH LEFT ADNEXECTOMY AND RIGHT SALPINGECTOMY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23879128 ↗
• MalfunctionDec 15, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. BESIDES, THIS SUTURE BROKE AS SOON AS IT WAS PULLED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IPS IS UNAVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802902 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR SEWED THE PATIENT, AND THE NEEDLE PULL OFF ISSUE HAPPENED WHEN THE NEEDLE WAS CLAMPED WITH THE NEEDLE HOLDER, WHICH PROLONGED THE OPERATION TIME AND INCREASED THE OPERATION RISK. A NEW SUTURE WAS REPLACED TO CONTINUE THE OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790784 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 1 ACTUAL PRODUCT AND 1 REPRESENTATIVE SAMPLE FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633139 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED. ON THE EVENING, THE PATIENT UNDERWENT PAINLESS DELIVERY. DURING THE SURGERY, MEDICAL STAFF SUTURED THE PATIENT, BUT SUDDENLY THE NEEDLE BROKE AND FELL INTO THE PATIENT'S BODY, CAUSING THE SURGERY TO BE INTERRUPTED. UNDER THE JOINT SEARCH OF MEDICAL STAFF, THE BROKEN NEEDLE WAS FOUND. AFTER REPLACING THE NEEDLE WITH A NEW ONE, THE SURGERY PROCEEDED NORMALLY AND A LIVE BABY GIRL WAS BORN. AFTER THE SURGERY, THE HOSPITAL WILL CONTINUE TO MONITOR THE PATIENT'S RECOVERY SITUATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018078 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 9:10, THE PATIENT UNDERWENT SURGERY. DURING THE SUTURING PROCESS, THE SUTURE BROKE. THE DOCTOR REPLACED THE SUTURE FOR THE PATIENT AND CONTINUED THE SURGERY. THE SURGERY ENDED AT 11:30 AND THE PATIENT RETURNED TO THE WARD SAFELY AFTER THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018023 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN USING SUTURE TO CLOSE THE ABDOMEN, THE SUTURE BROKE AT ONE-THIRD OF THE NEEDLE WITHOUT PULLING. UNABLE TO USE, URGENTLY REPLENISHED DURING SURGERY TO ENSURE SMOOTH OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968711 ↗
• MalfunctionApr 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A C-SECTION THAT DURING CLOSURE ON THE FIRST BITE THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883023 ↗