Coated VICRYL VCP358H (UDI 10705031052710)Recalls & reported problems

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 10705031052710), received between Oct 24, 2018 and Sep 25, 2026 — classified as 13 injuries, 299 malfunctions.

The most frequently reported specific device problem is “Break” (200 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 312 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Separation

  It was reported that a patient underwent a C-Section on (b)(6)2026 and suture was used. During the surgical process, when preparing to clamp and use the suture, it was found that the problem of pulling off suture needle happened. The use was immediately stopped and a new suture was replaced to continue suturing. There were no adverse patient consequences reported. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900704 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR UTERINE FIBROIDS AND UNDERWENT SURGERY. DURING THE OPERATION, THE CHIEF SURGEON SUTURED THE UTERINE MUSCLE LAYER ACCORDING TO ROUTINE PROCEDURES, BUT THE SUTURE TORE OFF AND BROKE. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE AND RE SUTURED THE UTERINE MUSCLE LAYER. THIS INCIDENT INCREASED THE PATIENT'S PAIN AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511640 ↗
• MalfunctionJun 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY AND HAD A THIRD PREGNANCY AND A FIRST DELIVERY. AT 38+1 WEEKS OF PREGNANCY, THE FIRST LIVE FETUS WAS WAITING FOR DELIVERY. PRE ECLAMPSIA. DURING THE OPERATION, THE SURGEON USED SUTURE TO SUTURE THE UTERUS, BUT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, MAKING IT IMPOSSIBLE TO SUTURE. THE SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING. THE INTERRUPTION OF SUTURING HAS AFFECTED THE SURGICAL PROCESS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435625 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, FROM 08:25 TO 09:25, THE PATIENT UNDERWENT SURGERY AND THE SUTURE WAS BROKEN WHEN USING. THE SUTURE WAS REPLACED IN TIME, AND NO FURTHER BREAKAGE OCCURRED AGAIN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355783 ↗
• MalfunctionMay 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY+BILATERAL ADNEXECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER CUTTING OFF THE UTERUS DURING HYSTERECTOMY+BILATERAL ADNEXECTOMY, THE DOCTOR USED SUTURE TO SUTURE THE REMAINING END OF THE UTERUS. AFTER THE SUTURE ENTERED THE ABDOMINAL CAVITY, THE CHIEF SURGEON PREPARED TO SUTURE IT. THE CHIEF SURGEON FOUND THAT THE SUTURE HAD FALLEN OFF FROM THE END OF THE NEEDLE AND THE NEEDLE COULD NO LONGER BE USED. THE CIRCULATING NURSE RE OPENED A NEEDLE OF THE SAME MANUFACTURER AND MODEL FOR THE CHIEF SURGEON TO CONTINUE SUTURING. AFTER THE SURGERY, THE RESIDUAL END WAS EXAMINED AND FOUND TO BE SUTURED WELL, AND THE PATIENT RETURNED TO THE WARD SAFELY . NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085507 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A INTRAPERITONEAL LOWER SEGMENT CESAREAN SECTION UNDER COMBINED SPINAL AND EPIDURAL ANESTHESIA PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY AT 05:15-06:10 DUE TO "PREGNANCY WITH A HISTORY OF CESAREAN SECTION AND IRREGULAR UTERINE CONTRACTIONS". DURING THE SURGERY, THE DOCTOR USED THIS SUTURE TO SUTURE THE UTERUS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR REPLACED THE SUTURE WITH A NEW ONE TO CONTINUE SUTURING THE UTERUS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929083 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE INTEGRITY AND EXPIRATION DATE OF THE OUTER PACKAGING OF THE SUTURE WERE CHECKED BEFORE SURGERY, AFTER CONFIRMING THEIR ACCURACY, THE SUTURE WAS USED AND HELD WITH A NEEDLE HOLDER. DURING THE SURGERY, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE PROCESS OF SUTURING THE UTERINE MUSCLE LAYER. THE OPERATION WAS IMMEDIATELY STOPPED AND A NEW SUTURE WAS REPLACED TO CONTINUE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873541 ↗
• MalfunctionMar 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AFTER GIVING BIRTH, A PREGNANT WOMAN WAS SUTURED BY A DOCTOR. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE. SUTURE DISCONNECTION MAY CAUSE OBSTRUCTION OF THE SUTURE PROCESS, LEADING TO INCREASED SURGICAL TIME, AND REPEATED PUNCTURES MAY ALSO RESULT IN TISSUE DAMAGE AND INFECTION RISK IN PATIENTS, DELAYING TREATMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500333 ↗
• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SUTURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 11:05, THE CERVICAL STUMP SUTURE WAS COMPLETED, AND THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING KNOTTING. THE MOBILE NURSE AND INSTRUMENT NURSE IMMEDIATELY CHECKED THE INTEGRITY OF THE NEEDLE AND SUTURE AND FOUND THAT THEY WERE INTACT. AFTER KNOTTING, THE SURGERY CONTINUED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283390 ↗
• MalfunctionFeb 5, 2026Break; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. WHEN USING SUTURE TO SUTURE THE UTERUS, THE TAIL OF THE SUTURE WAS ROUGH AND THE LENGTH WAS DIFFERENT FROM THE MARKED 90CM. THE SUTURE WAS ABOUT 50CM. THE SUTURE BROKE DURING USE AND WAS REPLACED FOR SUTURING, WHICH DELAYED THE SURGICAL PROCESS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270353 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE WOUND WITH THE SUTURE FOR THE PREGNANT WOMAN AFTER DELIVERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND NEW SUTURE WAS REPLACED IMMEDIATELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086139 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE WOUND WITH THE SUTURE FOR THE PREGNANT WOMAN AFTER DELIVERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SUTURE WAS REPLACED WITH A NEW ONE, AND THE OPERATION WAS INTERRUPTED AND THE OPERATION TIME WAS PROLONGED DUE TO SUTURE BREAKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086137 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE WAS USED TO SUTURE UTERUS, PERITONEUM AND ANTERIOR SHEATH TO STOP BLEEDING. DURING THE OPERATION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. REPLACED THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046597 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 23958171 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 23958169 ↗
• MalfunctionDec 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE OPERATION, AFTER SUTURING TWO STITCHES, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED .THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714836 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AFTER SEVERAL STITCHES, AND THE DOCTOR HAD NOT YET HAD TIME TO TIE THE KNOT. 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457849 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE INCISION WITH SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN DURING SUTURING. CHANGED TO A NEW SUTURE TO CONTINUE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285969 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE INCISION WITH SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN DURING SUTURING. CHANGED TO A NEW SUTURE TO CONTINUE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285929 ↗
• MalfunctionSep 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 08:40, WHEN THE UTERUS WAS SUTURED NORMALLY DURING THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND THE SUTURE COULD NOT BE CONTINUED. REPLACED WITH A NEW SUTURE FOR SUTURING AGAIN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057736 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE WAS USED DURING THE SURGERY AND THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SUTURE WAS REPLACED AND SUTURED AGAIN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577502 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING THE UTERUS DURING SURGERY. THE NEEDLE NEEDED TO BE RE-THREADED, WHICH PROLONGS THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577450 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE WAS USED TO SUTURE THE UTERUS AND WOUND DURING THE SURGERY. HOWEVER, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SUTURING PROCESS. 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 22577331 ↗
• MalfunctionJul 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. THE DELIVERY PROCESS OF THE FETUS WAS SMOOTH. WHEN THE SUTURE WAS USED FOR CONTINUOUS SUTURE OF THE UTERUS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE SUDDENLY HAPPENED. THE INSTRUMENT NURSE AND CIRCULATING NURSE URGENTLY EXAMINED THE INTEGRITY OF THE SUTURE NEEDLE AND TOOK THE STAGE FOR FURTHER EXAMINATION TO CONFIRM THAT THERE WAS NO RESIDUE IN THE ABDOMINAL CAVITY AT THE SAME TIME. SUBSEQUENTLY, A NEW SUTURE WAS USED TO CONTINUE SUTURING THE INCISION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532846 ↗
• MalfunctionJul 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AS SOON AS IT WAS USED DURING THE SURGERY, THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED, AFFECTING THE SURGICAL PROCESS. THE DOCTOR REPLACED THE SUTURE WITH ANOTHER BATCH NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22420821 ↗

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