Coated VICRYL VCP219HRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031051720), received between Jan 10, 2018 and Mar 12, 2026 — classified as 6 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MIXED HEMORRHOIDECTOMY SURGERY ON (B)(6) 2026, AND SUTURE WAS USED. DURING THE SUTURING BY THE DOCTOR, THE SUTURE WAS BROKEN WHEN PULLING THE SUTURE BEFORE KNOTTING TWICE. THE DOCTOR REPLACED IT WITH A NEW ONE TO CONTINUE THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579308 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED TO SEW SKIN IN CONTINUOUS INTRADERMAL SEWING. THE INTRAOPERATIVE SUTURING WAS SMOOTH. POST-OP, 1 TO 3 DAYS AFTER THE SURGERY, IT WAS FOUND BLISTERS ON THE LOWER ABDOMINAL WOUND OF THE SKIN, WITH REDNESS AND SWELLING AROUND THE BLISTERS. THE PATIENT HAD NO ABNORMAL SENSATION SUCH AS PAIN. THE DOCTOR PUNCTURED THE BLISTER AND CHANGED DRESSINGS FOR SEVERAL TIMES (SPECIFIC MEDICATION WAS UNKNOWN), AND THEN THE WOUND HEALING WAS IMPROVED. NO SUBSEQUENT ADVERSE EVENTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED,

  Patient problems: Blister; Impaired Healing; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 22435511 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION ON (B)(6) 2025 AND SUTURE WAS USED TO SEW SKIN IN CONTINUOUS INTRADERMAL SEWING. ON (B)(6) 2025, DURING FIRST DRESSING CHANGE, IT FOUND BLISTERS ON THE LOWER ABDOMINAL WOUND OF THE SKIN, WITH REDNESS AND SWELLING AROUND THE BLISTERS. THE PATIENT HAD NO ABNORMAL SENSATION SUCH AS PAIN. IT PUNCTURES LARGE BLISTERS, AND PROLONGS WOUND HEALING TIME, INCREASES THE NUMBER OF DRESSING CHANGES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Erythema; Impaired Healing; Swelling/ Edema

  MAUDE report 22318867 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTOCOLECTOMY PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SEWING DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. 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 20440038 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250977 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632071 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632055 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. TWO PRODUCTS HAD THE SAME ISSUE. 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 19629385 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024, AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. TWO PRODUCTS HAD THE SAME ISSUE. 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 19629358 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. TWO PRODUCTS HAVE THE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623219 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. TWO PRODUCTS HAVE THE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623215 ↗
• MalfunctionJun 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGERY WAS COMPLETED AND WHEN SUTURING THE WOUND, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED ANOTHER ONE TO COMPLETED THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558800 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED DIFFICULT TO USE BECAUSE THE NEEDLE AND THREAD KEEP SEPARATING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768178 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED DIFFICULT TO USE BECAUSE THE NEEDLE AND THREAD KEEP SEPARATING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767870 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED FOR INTRADERMAL CONTINUOUS SUTURING OF THE INCISION SKIN. POST-OP, THE PATIENT HAD WOUND HEALING ISSUES. ABOUT 5 DAYS AFTER THE SURGERY, THE PATIENT REPORTED BLISTER-LIKE PROTRUSIONS AT THE INCISION. THE BLISTER WAS PUNCTURED BY THE DOCTOR AND DISINFECTION TREATMENT WAS GIVEN. THE PATIENT IS CURRENTLY STABLE. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Impaired Healing

  MAUDE report 18149469 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED FOR INTRADERMAL CONTINUOUS SUTURING OF THE INCISION SKIN. POST-OP, THE PATIENT HAD A WOUND HEALING ISSUES. ABOUT 5 DAYS AFTER THE SURGERY, THE PATIENT REPORTED BLISTER-LIKE PROTRUSIONS AT THE INCISION. THE BLISTER WAS PUNCTURED BY THE DOCTOR AND DISINFECTION TREATMENT WAS GIVEN. THE PATIENT IS CURRENTLY STABLE. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Impaired Healing

  MAUDE report 18149463 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION ON (B)(6) 2023 AND SUTURE WAS USED TO SEW THE SKIN. THE PATIENT DEVELOPED A POST-OP WOUND HEALING ISSUE. AROUND 5 DAYS AFTER SURGERY, THE PATIENT REPORTED BLISTER-LIKE PROTRUSIONS AT THE INCISION. THEN THE BLISTER WAS PUNCTURED AND DISINFECTED. THE PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Impaired Healing

  MAUDE report 18010851 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2023 AND SUTURE WAS USED TO SUTURE THE LATERAL EPISIOTOMY PORTION OF THE PATIENT. DURING THE PROCEDURE, AFTER THE MIDWIFE HAS SEWED MORE THAN TEN STITCHES, THE MIDWIFE NEEDED TO HIDE THE SUTURE INTO THE VAGINA AND PASSED IT THROUGH THE VAGINAL OPENING. AT THIS POINT, IT WAS FOUND THAT THE NEEDLE WAS BROKEN IN THE VAGINAL TISSUE. THE MIDWIFE CAREFULLY SEARCHED FOR A BROKEN NEEDLE IN THE VAGINAL TISSUE AND TOOK IT OUT. WHEN TAKING IT OUT, IT CAUSED PUNCTURE INJURY TO THE PATIENT. THE ORIGINAL SUTURE WAS TAKEN OUT TOGETHER, AND UPON EXAMINATION, THE TAIL OF THE NEEDLE WAS BROKEN. THE REAR MIDWIFE USED ANOTHER SUTURE THAT WAS PREVIOUSLY PUNCTURED TO KNOT AND COMPLETE THE SUTURE. DUE TO THE TIMELY DETECTION, THE BROKEN NEEDLE DID NOT REMAIN IN THE TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16644029 ↗
• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS INTACT AT THE PRE-OPERATIVE CHECK. THE NEEDLE BROKE INTRA-OP WHEN SEWING UNKNOWN TISSUE. THE BROKEN TIP WAS FINALLY FOUND DURING THE SAME PROCEDURE. THE SURGERY WAS PROLONGED ABOUT TWO HOURS. THE PATIENT IS GOOD NOW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15872338 ↗
• MalfunctionNov 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING SEWING SUBCUTANEOUS TISSUE 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 15780518 ↗
• MalfunctionJul 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE REPORTED SUTURE DETACHED FROM THE SWAGED END OF THE NEEDLE DURING USAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015417 ↗
• MalfunctionMar 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RESECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN PIERCING THROUGH THE SKIN TO SEW DURING THE SURGERY OF RESECTION OF BACK MASS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474424 ↗
• MalfunctionApr 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN IT WAS ABOUT TO SEW THE OVARY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000889 ↗
• InjuryJan 10, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2017 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE DURING THE PROCEDURE AND AFTER THE PROCEDURE, THE NEEDLE WAS MISSING. CT TEST WAS PERFORMED TO LOCATE THE NEEDLE. THE PROCEDURE WAS PROLONGED 2 HOURS. THE NEEDLE WAS RETRIEVED FROM THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 7178181 ↗

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