Coated VICRYL VCP458H (UDI 10705031053373)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031053373), received between Nov 6, 2018 and Apr 20, 2026 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE PRODUCT WAS OPENED FOR USE DURING SURGERY. IT WAS FOUND THAT THERE WAS SOMETHING LIKE A HUMAN HAIR AFTER THE PACKAGE WAS OPENED AND THE PRODUCT WAS NOT USED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927764 ↗
• MalfunctionApr 2, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THE SUTURE WAS BROKEN AND THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766587 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING CAT OOPHORECTOMY, THE VETERINARIAN USES VICRYL PLUS VCP458H FOR OVARIAN PEDICLE LIGATION, MUSCLE WALL OVERSPRAY AND SKIN OVERSPRAY. WHEN THE VETERINARIAN CLAMPS HER LIGATION KNOT, THE SUTURE BROKE ON THE SIDE OF THE SMALL HEAD (THE ONE HELD IN THE NEEDLE HOLDER) BETWEEN THE KNOT AND THE JAWS OF THE NEEDLE HOLDER, WITHOUT EXERTING EXCESSIVE TENSION AND USING THE USUAL SURGICAL EQUIPMENT. THIS OCCURRED 3 TIMES DURING THE SURGERY ((B)(6)) AND ONCE DURING THE 2TH SURGERY (B)(6) THE SURGERIES COULD BE COMPLETED, USING A NEW SUTURE, WITHOUT AFFECTING THE ANIMALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357153 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING CAT OOPHORECTOMY, THE VETERINARIAN USES VICRYL PLUS VCP458H FOR OVARIAN PEDICLE LIGATION, MUSCLE WALL OVERSPRAY AND SKIN OVERSPRAY. WHEN THE VETERINARIAN CLAMPS HER LIGATION KNOT, THE SUTURE BROKE ON THE SIDE OF THE SMALL HEAD (THE ONE HELD IN THE NEEDLE HOLDER) BETWEEN THE KNOT AND THE JAWS OF THE NEEDLE HOLDER, WITHOUT EXERTING EXCESSIVE TENSION AND USING THE USUAL SURGICAL EQUIPMENT. THIS OCCURRED 3 TIMES DURING THE 1ST SURGERY (B)(6) AND ONCE DURING THE 2ND SURGERY (B)(6). THE SURGERIES COULD BE COMPLETED, USING A NEW SUTURE, WITHOUT AFFECTING THE ANIMALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357116 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING CAT OOPHORECTOMY, THE VETERINARIAN USES VICRYL PLUS VCP458H FOR OVARIAN PEDICLE LIGATION, MUSCLE WALL OVERSPRAY AND SKIN OVERSPRAY. WHEN THE VETERINARIAN CLAMPS HER LIGATION KNOT, THE SUTURE BROKE ON THE SIDE OF THE SMALL HEAD (THE ONE HELD IN THE NEEDLE HOLDER) BETWEEN THE KNOT AND THE JAWS OF THE NEEDLE HOLDER, WITHOUT EXERTING EXCESSIVE TENSION AND USING THE USUAL SURGICAL EQUIPMENT. THIS OCCURRED 3 TIMES DURING THE 1TH SURGERY (B)(6) AND ONCE DURING THE 2TH SURGERY (B)(6). THE SURGERIES COULD BE COMPLETED, USING A NEW SUTURE, WITHOUT AFFECTING THE ANIMALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357115 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING CAT OOPHORECTOMY, THE VETERINARIAN USES VICRYL PLUS VCP458H FOR OVARIAN PEDICLE LIGATION, MUSCLE WALL OVERSPRAY AND SKIN OVERSPRAY. WHEN THE VETERINARIAN CLAMPS HER LIGATION KNOT, THE SUTURE BROKE ON THE SIDE OF THE SMALL HEAD (THE ONE HELD IN THE NEEDLE HOLDER) BETWEEN THE KNOT AND THE JAWS OF THE NEEDLE HOLDER, WITHOUT EXERTING EXCESSIVE TENSION AND USING THE USUAL SURGICAL EQUIPMENT. THIS OCCURRED 3 TIMES DURING THE 1ST SURGERY (B)(6) AND ONCE DURING THE 2ND SURGERY (B)(6). THE SURGERIES COULD BE COMPLETED, USING A NEW SUTURE, WITHOUT AFFECTING THE ANIMALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357114 ↗
• MalfunctionApr 30, 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, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THIS OCCURRED IN 3-4 CASES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934371 ↗
• MalfunctionApr 30, 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, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THIS OCCURRED IN 3-4 CASES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934367 ↗
• MalfunctionApr 30, 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, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THIS OCCURRED IN 3-4 CASES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934366 ↗
• MalfunctionApr 30, 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, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THIS OCCURRED IN 3-4 CASES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934365 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CERVICAL SPINAL CANAL ENLARGEMENT FOR CERVICAL SPONDYLOTIC MYELOPATHY ON (B)(6) 2024 AND SUTURE WAS USED. A WEEK AFTER THE PROCEDURE, REDNESS INFLAMMATION HAD OCCURRED. EXUDATE DID NOT STOP FLOWING OUT. THE DOCTOR OPENED THE WOUND 2WEEKS AFTER THE PROCEDURE AND CONFIRMED INSIDE THE WOUND. THE INFLAMMATION WAS NOT CONFIRMED ON FASCIA, BUT INFLAMMATION WAS CONFIRMED ON SUBCUTANEOUS. SINCE THE JELLY-LIKE SUBSTANCE WAS PRESENT UNDER THE SKIN, THE DOCTOR THOUGHT THAT THE JELLY-LIKE SUBSTANCE WAS A DISSOLVED SUTURE. THE INFLAMMATION OCCURRED ON THE EDGE, AND THE DOCTOR REMOVED THE SUTURE, WHICH HAD BEEN USED ON THE INFLAMMATION PART OF THE SUBCUTANEOUS. THE INFLAMMATION WAS REDUCED ON SUTURE REMOVED PART, BUT THE INFLAMMATION ON OTHER PART WAS CONTINUED, AND HYPERTROPHIC SCAR OCCURRED. THE DOCTOR THOUGHT THAT THE PRODUCT IS RESPONSIBLE FOR THE APPEARANCE OF SYMPTOMS BECAUSE HYPERTROPHIC SCAR HAS APPEARED IN THE AREA WHERE THE PRODUCTS WERE LOCATED UNDER THE SKIN. THE DOCTOR DID NOT THINK IT'S SSI: SURGICAL SITE INFECTION. AFTER THAT, EXUDATE FLOWING OUT STOPPED. THE STEROIDS WERE APPLIED TO REDUCE INFLAMMATION. THE DOCTOR THINKS IT?S CONTACT DERMATIT

  Patient problems: Fluid Discharge; Inflammation; Pocket Erosion; Scar Tissue; Skin Inflammation/ Irritation

  MAUDE report 19538916 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE TIP WAS BROKEN DURING CONTINUOUS SUTURE ON SUBCUTANEOUS. NO BROKEN NEEDLE FELL INTO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318617 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN AT WHICH SUTURE DOESN¿T BREAK USUALLY DURING USE. THERE WERE NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759119 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN AT WHICH SUTURE DOESN¿T BREAK USUALLY DURING USE.. THERE. THERE WERE NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759115 ↗
• MalfunctionNov 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN THE SURGEON WAS TRYING TO SEW SUBCUTANEOUS, THE NEEDLE CAME OFF WHEN IT CAME OUT OF THE TISSUE, DURING CONTINUOUS SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749206 ↗
• MalfunctionAug 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191556 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TKA PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. AROUND 2 WEEKS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED INFECTION. THE DOCTOR COMMENTED THAT TREATMENT FOR INFECTION WAS DONE, BUT DETAIL IS UNKNOWN. THE CURRENT PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 8042849 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TKA ON UNKNOWN DATE AND SUTURE WAS USED. AROUND 2 WEEKS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED INFECTION. THE DOCTOR COMMENTED THAT TREATMENT FOR INFECTION WAS DONE, BUT DETAIL IS UNKNOWN. THE CURRENT PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 8042617 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TKA ON UNKNOWN DATE AND SUTURE WAS USED. AROUND 2 WEEKS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED INFECTION. THE DOCTOR COMMENTED THAT TREATMENT FOR INFECTION WAS DONE, BUT DETAIL IS UNKNOWN. THE CURRENT PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 8042572 ↗

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