Coated VICRYL VCP518H (UDI 10705031054042)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031054042), received between Jul 17, 2019 and Jan 22, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (13 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.

• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, THE WOUND RE-OPENED WITHIN ONE MONTH. THE PATIENT HAD INFLAMMATION AROUND THE STAPLES THAT DISAPPEARED WITHIN 24 HOURS AFTER THEIR REMOVAL. THEN THE WOUND REOPENED WITH THE SUTURE PROTRUDING AND AN INFLAMMATORY PLAQUE. THEREFORE, THE SURGEON SUSPECTED AN INFECTION. HOWEVER, FUNCTION WAS VERY GOOD AND LABORATORY TESTS WERE COMPLETELY NORMAL. THE DISCHARGE DID NOT PERSIST. THE SCAR IS STILL RED BUT THE OPENING HAS CLOSED AND THE PATIENT CAN WALK FOR LONG PERIODS WITHOUT PAIN AND CONTINUES TO IMPROVE EVERY DAY. THE PATIENT IS THEREFORE PROGRESSING FAVORABLY AFTER HE WAS NEARLY TAKEN BACK TO THE OR FOR PRESUMED EARLY INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Skin Inflammation/ Irritation; Unspecified Infection; Wound Dehiscence

  MAUDE report 24148917 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2025 AND SUTURE WAS USED. POST-OPERATION, THE WOUND RE-OPENED WITHIN ONE MONTH. THE SUTURE WAS PROTRUDING FROM A CLOSED WOUND. THE SCAR HAD BEEN PERFECT UNTIL NOW (FOR THE MOMENT THE SUTURE IS COMING OUT "BY ITSELF"), WHICH MADE THE SURGEON LOOK FOR A CAUSE OTHER THAN SUPERFICIAL CONTAMINATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Skin Inflammation/ Irritation; Unspecified Infection; Wound Dehiscence

  MAUDE report 24148816 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OTV ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE WOUND RE-OPENED WITHIN ONE MONTH. THE PATIENT HAD A WEEPING OPENING AND THE SUTURE IN THE MIDDLE, AND DATES BACK A MONTH OR TWO. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Skin Inflammation/ Irritation; Unspecified Infection; Wound Dehiscence

  MAUDE report 24148805 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BROKE WHILE TYING THE KNOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039533 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY PROCEDURE (B)(6) 2025 AND A SUTURE WAS USED. ON THE MORNING, DURING SURGERY, THE DOCTOR WAS SUTURING THE UTERINE MUSCLE LAYER WHEN THE NEEDLE BROKE IN TWO FROM THE MIDDLE. AFTER SEARCHING FOR A LONG TIME IN THE MUSCLE LAYER, THE BROKEN HALF WAS FOUND, AND AFTER COMPARING AND CONFIRMING ITS INTEGRITY, A NEW SUTURE WAS UNPACKED AND USED. AFTER CONFIRMING ITS INTEGRITY, IT WAS CONTINUED TO BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306737 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC REMOVAL OF UTERINE FIBROIDS ON (B)(6) 2024 AND SUTURE WAS USED. WHILE SUTURING THE UTERUS DURING SURGERY, THE NEEDLE BROKE IN THE ABDOMINAL CAVITY. THE DOCTOR FOUND THE BROKEN NEEDLE AND REMOVED IT, CHECKED ITS INTEGRITY, AND REPLACED IT WITH A NEW SUTURE. THE SURGERY PROCEEDED SMOOTHLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952219 ↗
• MalfunctionNov 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE OCCURRED WHILE SEWING THE UTERINE INCISION IN SURGERY. THE NEEDLE WAS SEARCHED IN THE ABDOMINAL CAVITY FOR NEARLY HALF AN HOUR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837508 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS REPORTED THAT ABOUT 1 MM OF THE NEEDLE TIP BROKE WHEN SEWING THE UTERUS IN THE SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219701 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE STRAND DETACHED FROM THE SWAGE OF NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510788 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT FIBROID PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY OF FIBROID. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324809 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT FIBROID PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY OF FIBROID. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324791 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT FIBROID PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY OF FIBROID. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324788 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT FIBROID PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY OF FIBROID. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324781 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING THE INCISION. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE ARE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246044 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROMYOMECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN KNOTTING AFTER SEWING THE VAGINAL STUMP, THE SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105374 ↗
• MalfunctionSep 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SEWING, THE SUTURE BROKE. CHANGED TO A LIKE DEVICE TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964387 ↗
• MalfunctionSep 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SEWING, THE SUTURE BROKE. CHANGED TO A LIKE DEVICE TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964382 ↗
• MalfunctionSep 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SEWING, THE SUTURE BROKE. CHANGED TO A LIKE DEVICE TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964381 ↗
• MalfunctionAug 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUBTOTAL HYSTERECTOMY PROCEDURE AND SUTURE WAS USED. THE NEEDLE PULL OFF SUTURE NEEDLE WHEN SUTURING THE CERVICAL STUMP. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889362 ↗
• MalfunctionJul 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE STRANDS DETACHED FORM SWAGE OF THE SURGICAL NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801077 ↗
• MalfunctionJul 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE STRAND DETACHED FORM SWAGE OF THE SURGICAL NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801051 ↗

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