Coated VICRYL VCP353H (UDI 10705031052659)Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10705031052659), received between Nov 20, 2017 and Jun 12, 2025 — classified as 5 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Material Separation” (52 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE CONSISTENTLY PULLING OUT FROM THE NEEDLES, WHICH POSES A RISK TO PROCEDURAL EFFICIENCY AND PATIENT SAFETY. THIS PROBLEM HAS LED TO UNNECESSARY USE OF ADDITIONAL SUTURES WHICH INCREASING BOTH TIME AND COST. WE SUSPECT THERE MAY BE A QUALITY PROBLEM WITH THE NEEDLE-SUTURE ATTACHMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193846 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE CONSISTENTLY PULLING OUT FROM THE NEEDLES, WHICH POSES A RISK TO PROCEDURAL EFFICIENCY AND PATIENT SAFETY. THIS PROBLEM HAS LED TO UNNECESSARY USE OF ADDITIONAL SUTURES WHICH INCREASING BOTH TIME AND COST. WE SUSPECT THERE MAY BE A QUALITY PROBLEM WITH THE NEEDLE-SUTURE ATTACHMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193844 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE CONSISTENTLY PULLING OUT FROM THE NEEDLES, WHICH POSES A RISK TO PROCEDURAL EFFICIENCY AND PATIENT SAFETY. THIS PROBLEM HAS LED TO UNNECESSARY USE OF ADDITIONAL SUTURES WHICH INCREASING BOTH TIME AND COST. WE SUSPECT THERE MAY BE A QUALITY PROBLEM WITH THE NEEDLE-SUTURE ATTACHMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193670 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE CONSISTENTLY PULLING OUT FROM THE NEEDLES, WHICH POSES A RISK TO PROCEDURAL EFFICIENCY AND PATIENT SAFETY. THIS PROBLEM HAS LED TO UNNECESSARY USE OF ADDITIONAL SUTURES WHICH INCREASING BOTH TIME AND COST. WE SUSPECT THERE MAY BE A QUALITY PROBLEM WITH THE NEEDLE-SUTURE ATTACHMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193668 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE CONSISTENTLY PULLING OUT FROM THE NEEDLES, WHICH POSES A RISK TO PROCEDURAL EFFICIENCY AND PATIENT SAFETY. THIS PROBLEM HAS LED TO UNNECESSARY USE OF ADDITIONAL SUTURES WHICH INCREASING BOTH TIME AND COST. WE SUSPECT THERE MAY BE A QUALITY PROBLEM WITH THE NEEDLE-SUTURE ATTACHMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193666 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APAROSCOPIC MYOMECTOMY AND HYSTEROSCOPIC CERVICAL POLYPECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY FOR UTERINE FIBROIDS IN THE MORNING. DURING THE OPERATION, THE DOCTOR USED SUTURE TO SUTURE THE UTERUS. UNDER NORMAL FORCE, THREE CONSECUTIVE SUTURES BROKE AND COULD NOT CONTINUE SUTURING. THE DOCTOR REPLACED ANOTHER BATCH OF SUTURES OF THE SAME MODEL TO COMPLETE THE SURGICAL SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065037 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APAROSCOPIC MYOMECTOMY AND HYSTEROSCOPIC CERVICAL POLYPECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY FOR UTERINE FIBROIDS IN THE MORNING. DURING THE OPERATION, THE DOCTOR USED SUTURE TO SUTURE THE UTERUS. UNDER NORMAL FORCE, THREE CONSECUTIVE SUTURES BROKE AND COULD NOT CONTINUE SUTURING. THE DOCTOR REPLACED ANOTHER BATCH OF SUTURES OF THE SAME MODEL TO COMPLETE THE SURGICAL SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064935 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APAROSCOPIC MYOMECTOMY AND HYSTEROSCOPIC CERVICAL POLYPECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY FOR UTERINE FIBROIDS IN THE MORNING. DURING THE OPERATION, THE DOCTOR USED SUTURE TO SUTURE THE UTERUS. UNDER NORMAL FORCE, THREE CONSECUTIVE SUTURES BROKE AND COULD NOT CONTINUE SUTURING. THE DOCTOR REPLACED ANOTHER BATCH OF SUTURES OF THE SAME MODEL TO COMPLETE THE SURGICAL SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064912 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLE FASCIA. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. 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 20930038 ↗
• InjuryDec 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TOP OF NEEDLE BROKE OFF. THE PATIENT NEEDED AN X-RAY TO RULE OUT MISSING/LEFT PRODUCT. THE PATIENT REQUIRED CONVERSION TO A GENERAL AESTHETIC DUE TO THE DELAY IN COMPLETION OF PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20843534 ↗
• InjurySep 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS CLOSING THE UTERUS, THE FIRST LAYER WAS DONE AND COMPLETED. WHEN THE SURGEON STARTED TO MAKE THE SECOND LAYER WITH TAKING THE FIRST BITE, THE NEEDLE LEFT THE THREAD AND FELL INSIDE THE UTERUS. THE SURGEON HAD TO OPEN THE PATIENT AGAIN TO FIND THE NEEDLE. THE SURGERY WAS DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20183713 ↗
• InjuryAug 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC RESECTION OF PANCREATIC LESIONS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN IT PASSED THROUGH THE ABDOMINAL WALL AND OUT OF THE ABDOMEN, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED , LEAVING THE NEEDLE IN THE ABDOMINAL MUSCLE. AFTER SEARCHING WITH A LAPAROSCOPE, IT WAS UNSUCCESSFUL. THE PATIENT WAS ANESTHETIZED AND THE POSITION OF THE NEEDLE IN THE ABDOMINAL WALL WAS DETERMINED BY B-ULTRASOUND POSITIONING. A SMALL INCISION WAS MADE TO REMOVE THE NEEDLE, CAUSING HARM TO THE PATIENT DURING THE SECOND SURGERY. THE PATIENT RECOVERED AND WAS DISCHARGED ON THE 11TH DAY AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19940174 ↗
• MalfunctionJul 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BY A SALES REP THE SUTURE WAS BROKEN EASILY EVEN THOUGH PULLED LIGHTLY FROM THE SWAGE PART OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878242 ↗
• MalfunctionJul 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BY A SALES REP THE SUTURE WAS BROKEN EASILY EVEN THOUGH PULLED LIGHTLY FROM THE SWAGE PART OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878239 ↗
• MalfunctionJul 31, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878238 ↗
• MalfunctionJul 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BY A SALES REP THE SUTURE WAS BROKEN EASILY EVEN THOUGH PULLED LIGHTLY FROM THE SWAGE PART OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878237 ↗
• MalfunctionJul 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BY A SALES REP THE SUTURE WAS BROKEN EASILY EVEN THOUGH PULLED LIGHTLY FROM THE SWAGE PART OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878236 ↗
• MalfunctionJul 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BY A SALES REP THE SUTURE WAS BROKEN EASILY EVEN THOUGH PULLED LIGHTLY FROM THE SWAGE PART OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878235 ↗
• MalfunctionJul 19, 2024Material Frayed; Product Quality Problem; Material Frayed; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THIS CASE IS FROM HEALTH AUTHORITY. DURING PREOPERATIVE PREPARATION, THE HEAD NURSE OF THE OPERATING ROOM FOUND THAT THE SUTURE WAS ONLY 30CM LONG AND THE TAIL THREAD WAS ROUGH, MAKING IT UNUSABLE. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784147 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. CUSTOMER REPORTED HAVING ISSUES WITH SUTURE WHERE THE SUTURE IS PULLING AWAY FROM THE NEEDLE. ALL WITH THE SAME LOT. NEW SUTURES WERE OPENED. PROCEDURE WAS COMPLETED WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216535 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. CUSTOMER REPORTED HAVING ISSUES WITH SUTURE WHERE THE SUTURE IS PULLING AWAY FROM THE NEEDLE. ALL WITH THE SAME LOT. NEW SUTURES WERE OPENED. PROCEDURE WAS COMPLETED WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216509 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. CUSTOMER REPORTED HAVING ISSUES WITH SUTURE WHERE THE SUTURE IS PULLING AWAY FROM THE NEEDLE. ALL WITH THE SAME LOT. NEW SUTURES WERE OPENED. PROCEDURE WAS COMPLETED WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216316 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. CUSTOMER REPORTED HAVING ISSUES WITH SUTURE WHERE THE SUTURE IS PULLING AWAY FROM THE NEEDLE. ALL WITH THE SAME LOT. NEW SUTURES WERE OPENED. PROCEDURE WAS COMPLETED WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216135 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. CUSTOMER REPORTED HAVING ISSUES WITH SUTURE WHERE THE SUTURE IS PULLING AWAY FROM THE NEEDLE. ALL WITH THE SAME LOT. NEW SUTURES WERE OPENED. PROCEDURE WAS COMPLETED WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215048 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. CUSTOMER REPORTED HAVING ISSUES WITH SUTURE WHERE THE SUTURE IS PULLING AWAY FROM THE NEEDLE. ALL WITH THE SAME LOT. NEW SUTURES WERE OPENED. PROCEDURE WAS COMPLETED WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213845 ↗

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