Coated VICRYL VCP218HRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031051706), received between Jul 9, 2019 and May 20, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DELIVERY SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT NEEDLE BREAKAGE WAS OBSERVED. NEEDLE TIP HAD A HOOK. WHEN A MIDWIFE WAS SUTURING A WOUND IN THE DELIVERY ROOM, SHE FOUND THAT THE NEEDLE TIP OF THE MATCHING SUTURE HAD A HOOK, WHICH NOT ONLY INCREASED THE PAIN DURING THE SUTURING PROCESS BUT ALSO MAY RESULT IN POOR HEALING EFFECT OF THE WOUND. THE MIDWIFE IMMEDIATELY REPLACED THE SUTURE. AT SAME TIME, THE HCP ALSO CLAIMED THAT ANOTHER SIMILAR CASE HAD OCCURRED, PLS REFER TO (B)(4). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228995 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 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 25216011 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 4 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 22827538 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 4 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 22827537 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 4 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 22827531 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 4 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 22827530 ↗
• MalfunctionAug 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED ON THE TISSUE. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY, DURING PASSAGE THROUGH TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817824 ↗
• MalfunctionMay 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE MORNING, DURING THE PATIENT'S LAPAROSCOPIC HYSTERECTOMY SURGERY, THE CHIEF SURGEON, WHILE PREPARING FOR SUTURING, HAD JUST USED A NEEDLE HOLDER TO PICK UP THE NEEDLE WHEN THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SURGEON IMMEDIATELY REMOVED THE NEEDLE AND SUTURE FROM THE ABDOMINAL CAVITY WITHOUT ANY PROBLEMS, AND THE SURGERY PROCEEDED NORMALLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073073 ↗
• InjuryJun 14, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT FEFT SUBTOTAL THYROIDECTOMY, RIGHT SUBTOTAL THYROIDECTOMY, AND RECURRENT LARYNGEAL NERVE EXPLORATION UNDER GENERAL ANESTHESIA AND SUTURE WAS USED. SINCE THREE MONTHS AFTER SURGERY, THE PATIENT HAS HAD MULTIPLE SMALL PUSTULES AT THE SURGICAL INCISION, WHICH HAVE BEEN CLEANED, DISINFECTED, AND CHANGED DRESSING MULTIPLE TIMES BUT STILL CANNOT FULLY HEAL. THEREFORE, UPON EXAMINATION, IT WAS FOUND THAT THE SUTURE HAS NOT BEEN ABSORBED. THE UNABSORBED SUTURE WAS IMMEDIATELY REMOVED, AND THE PATIENT UNDERWENT DEBRIDEMENT OF THE SMALL PUSTULES. THE HEALING OF THE PATIENT'S INCISION WAS CLOSELY OBSERVED IN THE LATER STAGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Purulent Discharge

  MAUDE report 19539076 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED TO SEW THE SKIN. ABOUT 5 MONTHS AFTER THE SURGERY, THE PATIENT CAME BACK TO THE HOSPITAL FOR REEXAMINATION. THE DOCTOR FOUND A SMALL PUSTULE AT THE PATIENT'S INCISION SITE, AND THE SUTURE WAS FOUND EXTRUDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge

  MAUDE report 19270934 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED TO SEW THE SKIN. ABOUT 5 MONTHS AFTER THE SURGERY, THE PATIENT CAME BACK TO THE HOSPITAL FOR REEXAMINATION. THE DOCTOR FOUND A SMALL PUSTULE AT THE PATIENT'S INCISION SITE, AND THE SUTURE WAS FOUND EXTRUDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge

  MAUDE report 19270928 ↗
• MalfunctionFeb 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST MASS EXCISION ON (B)(6) 2024 AND A SUTURE WAS USED. PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SKIN SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775086 ↗
• MalfunctionDec 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT HAD A FINGER INJURY AND REQUIRED THE USE OF SUTURE DURING THE SURGERY. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276903 ↗
• MalfunctionMar 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2023 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 16500508 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, IT WAS REPORTED THAT THERE HAD BEEN NO NEEDLE TIP ON ONE NEEDLE IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER LIKE DEVICE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951664 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR REMOVAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE SUDDENLY. 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 13446434 ↗
• MalfunctionJan 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN DRAWING THE SUTURE TO SEW THE SKIN DURING THE 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 13187290 ↗
• MalfunctionFeb 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS CLOSING THE UTERUS WITH THE SUTURE, THE NEEDLE POPPED OFF THE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FOUR MINUTE DELAY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350059 ↗
• MalfunctionFeb 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS CLOSING THE UTERUS WITH THE SUTURE, THE NEEDLE POPPED OFF THE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FOUR MINUTE DELAY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349988 ↗
• MalfunctionNov 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE TIP WAS MISSING. DURING THE PROCEDURE, THE SUTURE WAS USED TO SEW THE DERMIS. HOWEVER, IT WAS FOUND THAT 1-2MM OF THE NEEDLE TIP WAS MISSING WHEN ALMOST FINISHING SEWING. WITH THE HELP OF AN X-RAY, IT TOOK ABOUT 2 HOURS TO LOOK FOR THE NEEDLE TIP, BUT FINALLY FAILED TO FIND IT. THE PATIENT IS NOW DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269792 ↗
• MalfunctionJul 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MASTECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING SEWING SOFT TISSUE, THE NEEDLE BROKE. IT WAS RETRIEVED AND EXCHANGED WITH NEW ONE TO COMPLETE. OPERATION TIME PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773782 ↗

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