Coated VICRYL VCP357HRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031052697), received between Mar 23, 2020 and Apr 23, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968676 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE SURGICAL PROCEDURE FOR THE PATIENT, THE SURGEON USED THE SUTURE NORMALLY TO SUTURE THE TISSUE. WHEN THE NEEDLE HOLDER WAS GRIPPING THE FRONT END OF THE NEEDLE, THE TIP OF THE NEEDLE SUDDENLY BROKE, AND THE SURGEON IMMEDIATELY STOPPED THE OPERATION. THE NEEDLE AND THE BROKEN END WERE REMOVED AND CHECKED BY THE CHIEF SURGEON, HAND WASHING NURSE, AND TOUR NURSE TO CONFIRM THE INTEGRITY OF THE NEEDLE. AFTER REPORTING, THE SUTURE WAS REPLACED AGAIN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444985 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY DUE TO OSTEOARTHRITIS OF THE LEFT KNEE JOINT. DURING THE SURGERY, THE SUTURE BROKE ABNORMALLY AND COULD NOT BE SUTURED. THE SURGERY WAS SUCCESSFULLY PERFORMED AFTER REPLACING THE SUTURE, AND THE PATIENT'S CONDITION IS CURRENTLY STABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783150 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY DUE TO OSTEOARTHRITIS OF THE LEFT KNEE JOINT. DURING THE SURGERY, THE SUTURE BROKE ABNORMALLY AND COULD NOT BE SUTURED. THE SURGERY WAS SUCCESSFULLY PERFORMED AFTER REPLACING THE SUTURE, AND THE PATIENT'S CONDITION IS CURRENTLY STABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783149 ↗
• MalfunctionOct 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, THE PATIENT CAME TO THE HOSPITAL FOR SURGERY DUE TO A "SCARRED UTERUS". DURING THE OPERATION, WHEN THE SUTURE WAS OPENED TO PREPARE FOR SUTURING, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AFFECTING THE PATIENT'S SUTURING. THE SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301342 ↗
• MalfunctionMay 22, 2025Material Separation; Material Separation

  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 PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073508 ↗
• MalfunctionFeb 4, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY . 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307138 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC RIGHT SALPINGECTOMY UNDER ANESTHESIA ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO ABDOMINAL PAIN FOR 2 HOURS AFTER 42 DAYS OF AMENORRHEA, ACCOMPANIED BY A SMALL AMOUNT OF VAGINAL BLEEDING. AFTER B-ULTRASOUND EXAMINATION, THE PATIENT'S UTERUS WAS FOUND TO BE OF NORMAL SIZE, AND NO GESTATIONAL SAC WAS FOUND IN THE UTERUS. A HETEROGENEOUS ECHO OF 20 * 12MM WAS OBSERVED IN THE RIGHT ADNEXAL AREA, AND A CLEAR LIQUID DARK AREA OF 16 * 9MM WAS OBSERVED IN THE PELVIC CAVITY. THE BLOOD HCG LEVEL INCREASED BY 671.7MIU/ML, AND THE DIAGNOSIS WAS ECTOPIC PREGNANCY. ON THE SECOND DAY OF ADMISSION, THE PATIENT RECEIVED MEDICAL ADVICE AND WAS ADMITTED TO THE HOSPITAL TO COMPLETE ALL PREOPERATIVE PREPARATIONS. THE SURGERY WAS PERFORMED UNDER ANESTHESIA. DURING THE NORMAL SURGICAL SUTURING PROCESS, THE NEEDLE BROKE AND FELL INTO THE ABDOMINAL CAVITY. THE OPERATING DOCTOR PROMPTLY DISCOVERED AND IMMEDIATELY SEARCHED FOR THE BROKEN NEEDLE. DUE TO THE SMALL SIZE OF THE NEEDLE, IT WAS DIFFICULT TO FIND. AFTER MORE THAN AN HOUR OF SEARCHING, THE NEEDLE WAS FINALLY REMOVED AND REPLACED WITH OTHER SUTURE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817090 ↗
• MalfunctionJul 9, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701567 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE NEEDLE DID NOT FELL INTO THE PATIENT. 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 18635780 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE NEEDLE DID NOT FELL INTO THE PATIENT. 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 18635733 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 11/1/2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW UTERINE. TIE THE KNOT IMMEDIATELY AND REPLACE IT WITH A NEW SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246042 ↗
• MalfunctionSep 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN THE SURGERY. 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 17785985 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 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 17497758 ↗
• MalfunctionJul 17, 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 THE SUTURE PULLING OFF THE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING SURGERY. 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 17332466 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE NEEDLE DID NOT FALL INTO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152792 ↗
• MalfunctionApr 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON 3/16/2023, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW INCISION. 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 16700615 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336710 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336695 ↗
• MalfunctionJul 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE PULLED OFF FROM THE NEEDLE DURING SEWING SUBCUTANEOUS FAT IN SURGERY. 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 15041627 ↗
• MalfunctionJul 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 15015811 ↗
• MalfunctionJul 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009283 ↗
• MalfunctionMay 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN SURGERY. 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 14339063 ↗
• MalfunctionDec 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER UTERINE CESAREAN SECTION ON (B)(6) 2021 AND SUTURE WAS USED. WHEN THE SURGEON SUTURED TWO-THIRDS OF THE FASCIA LAYER THE PROBLEM OF PULLING OFF THE SUTURE NEEDLE HAPPENED. AFTER CHECKING THAT THE NEEDLE WAS INTACT, ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932911 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869304 ↗

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