Coated VICRYL VCP417HRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10705031053038), received between Dec 21, 2018 and Aug 6, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Break” (35 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. May 10, 2024Class IIOpen, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2145-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159037 ↗
• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114267 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMORRHOID SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 19:00, WHILE USING SUTURE TO SUTURE TISSUE DURING SURGERY, IT WAS FOUND THAT THE SUTURE WAS EASY TO BREAK. UPON RE EXAMINATION OF THE OTHER PARTS OF THE SUTURE, IT WAS ALSO FOUND TO BE PRONE TO BREAKAGE. THE VISITING NURSE IMMEDIATELY CHANGED THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874426 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING THE MESH IMPLANTATION PORTION OF SURGERY THE TIP OF THE NEEDLE SHEARED OFF; UNABLE TO RETRIEVE. RETAINED NEEDLE TIP IN FASCIA AND MESH WAS REAPPLIED. NO HARM TO PATIENT; PATIENT INFORMED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24327425 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE SALES REP THAT THE NEEDLE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS GIVEN. PRODUCT IS AVAILABLE FOR RETURN. A FRACTURE WAS OBSERVED AT THE TIP OF THE RETURNED NEEDLE. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACE WAS NOT PROVIDED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. MECHANICAL DAMAGE OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDES ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236018 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A MYOMECTOMY PROCEDURE, THE SURGEON WAS CLOSING TROCAR INCISIONS WHEN THE NEEDLE BROKE. THE BROKEN NEEDLE WAS RETRIEVED AND DISCARDED, AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369243 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING ROBOTIC HYSTERECTOMY THE TIP OF THE NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798985 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SUBCUTANEOUS LAYER CLOSURE, THE NEEDLE BROKE. THE BROKEN PIECE WAS RETRIEVED WITH NO ADVERSE EFFECTS TO THE PATIENT. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CLOSURE WITHOUT ANY FURTHER ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993751 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE WHILE USING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871539 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, UPON VAGINAL CUFF CLOSURE, THE SUTURE BROKE AWAY FROM THE NEEDLE. WHEN APPLYING TENSION AFTER THE SURGEON TAKES A BITE, WHEN THEY GRASP THE SUTURE IS POPPING OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632660 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, UPON VAGINAL CUFF CLOSURE, THE SUTURE BROKE AWAY FROM THE NEEDLE. WHEN APPLYING TENSION AFTER THE SURGEON TAKES A BITE, WHEN THEY GRASP THE SUTURE IS POPPING OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632636 ↗
• MalfunctionDec 11, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD DOUBLE NEEDLES AND IT SHOULD HAVE BEEN SINGLE. NO PATIENT CONSEQUENCE WAS REPORTED. ONE DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905949 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF EASILY WHILE BEING LOADED INTO THE NEEDLE DRIVER. NO NEEDLE FELL INTO THE PATIENT AND NO PATIENT HARM. THEY GOT ANOTHER ONE TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913014 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE STRAND BROKE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154072 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A MASTECTOMY ON (B)(6) 2024, AND SUTURE WAS USED. AFTER THE FIRST BITE, THE TIP OF THE NEEDLE FELL OFF. THEY RETRIEVED THE NEEDLE BEFORE CLOSURE AND GOT ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963774 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, 3MM OF THE NEEDLE TIP BROKE OFF. AT THE TIME OF THE CALL IT WAS UNKNOWN HOW THE CASE WAS COMPLETED AND IT WAS UNKNOWN IF ANYTHING FELL INTO THE PATIENT. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838123 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERATOR CHANGE OF A PERMANENT PACEMAKER PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE LEFT CHEST INCISION SITE, THE SUTURE BROKE, AND A PORTION OF THE NEEDLE REMAINED IN THE POCKET. THE PHYSICIAN HAD TO REOPEN THE INCISION SITE AND REMOVE THE GENERATOR TO RETRIEVE THE BROKEN SUTURE. THE RETRIEVAL OF THE BROKEN SUTURE NEEDLE WAS SUCCESSFUL. UNKNOWN IF THE DEVICE IS RETURNED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677039 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THEY HAVE HAD MULTIPLE NEEDLES HAVE BROKEN OFF AT THE TIP DURING VARIOUS PROCEDURES. NO PATIENT HARM REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454327 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A SIGMOIDECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF WHILE SUTURING TISSUE OF THE COLON. FRAGMENT WAS RECOVERED FROM THE PATIENT. NO EXTRA STEPS WERE NEEDED TO LOCATE THE FRAGMENT. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418806 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A VAGINAL DELIVERY ON 14-NOV-2023 AND SUTURE WAS USED. ADULT FEMALE DELIVERED BABY VAGINALLY. WHILE REPAIRING A LACERATION AS A RESULT OF DELIVERY, IT WAS NOTICED THAT THE NEEDLE "BROKE" AND TIP COULD NOT BE LOCATED. X-RAY CONFIRMED THAT THE TIP WAS IN THE PATIENT'S SOFT TISSUE. IT WAS REMOVED WITHOUT DIFFICULTY AND NO KNOWN HARM TO THE PATIENT. X-RAY PERFORMED TO LOCATE TIP OF NEEDLE. TIP REMOVED FROM SOFT TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411161 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THEY HAVE HAD MULTIPLE NEEDLES HAVE BROKEN OFF AT THE TIP DURING VARIOUS PROCEDURES (HEMORRHOIDECTOMY, COLON RESECTION) FOR DR. LEWIS. THEY DID NOT RETAIN ANY OF THE AFFECTED, NON-STERILE SUTURE USED IN THE PROCEDURE. I AM IN POSSESSION OF THE REMAINDER OF THE STERILE BOX. THERE WAS A DELAY (OPENING NEW PACK) AND FRAGMENTS WERE MADE. NO PATIENT HARM REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340752 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THEY HAVE HAD MULTIPLE NEEDLES HAVE BROKEN OFF AT THE TIP DURING VARIOUS PROCEDURES (HEMORRHOIDECTOMY, COLON RESECTION) FOR DR. LEWIS. THEY DID NOT RETAIN ANY OF THE AFFECTED, NON-STERILE SUTURE USED IN THE PROCEDURE. I AM IN POSSESSION OF THE REMAINDER OF THE STERILE BOX. THERE WAS A DELAY (OPENING NEW PACK) AND FRAGMENTS WERE MADE. NO PATIENT HARM REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340748 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THEY HAVE HAD MULTIPLE NEEDLES HAVE BROKEN OFF AT THE TIP DURING VARIOUS PROCEDURES (HEMORRHOIDECTOMY, COLON RESECTION) FOR DR. LEWIS. THEY DID NOT RETAIN ANY OF THE AFFECTED, NON-STERILE SUTURE USED IN THE PROCEDURE. I AM IN POSSESSION OF THE REMAINDER OF THE STERILE BOX. THERE WAS A DELAY (OPENING NEW PACK) AND FRAGMENTS WERE MADE. NO PATIENT HARM REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340747 ↗
• MalfunctionDec 15, 2023Break; Break

  SALES REP REPORTED THAT THEY HAVE HAD MULTIPLE NEEDLES HAVE BROKEN OFF AT THE TIP DURING VARIOUS PROCEDURES (HEMORRHOIDECTOMY, COLON RESECTION) FOR DR. LEWIS. THEY DID NOT RETAIN ANY OF THE AFFECTED, NON-STERILE SUTURE USED IN THE PROCEDURE. I AM IN POSSESSION OF THE REMAINDER OF THE STERILE BOX. THERE WAS A DELAY (OPENING NEW PACK) AND FRAGMENTS WERE MADE. NO PATIENT HARM REPORTED. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340746 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THEY HAVE HAD MULTIPLE NEEDLES HAVE BROKEN OFF AT THE TIP DURING VARIOUS PROCEDURES (HEMORRHOIDECTOMY, COLON RESECTION) FOR DR. LEWIS. THEY DID NOT RETAIN ANY OF THE AFFECTED, NON-STERILE SUTURE USED IN THE PROCEDURE. I AM IN POSSESSION OF THE REMAINDER OF THE STERILE BOX. THERE WAS A DELAY (OPENING NEW PACK) AND FRAGMENTS WERE MADE. NO PATIENT HARM REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340741 ↗

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-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