Coated VICRYL VCP442H (UDI 10705031053298)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10705031053298), received between Oct 16, 2018 and May 26, 2026 — classified as 1 death, 23 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT GAVE BIRTH TO A BABY GIRL VIA VAGINA WITH LOA POSITION BY CUTTING LOW FORCEPS AT THE PERINEUM SIDE DUE TO STAGNATION OF PRESENTATION, FGR, ONCE PREGNANCY, ZERO DELIVERY, 39 WEEKS PREGNANCY AND ANEMIA DURING PREGNANCY ON (B)(6) 2026 AND SUTURE WAS USED INTRADERMALLY. TEN DAYS AFTER OPERATION, IT WAS FOUND THAT THE SUTURE HAD NOT BEEN ABSORBED AND WAS EMERGING, INDICATING INCOMPLETE/POOR WOUND HEALING AND REQUIRING RE SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 25280833 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE TALOFIBULAR ANTERIOR LIGAMENT REPAIR SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGERY WENT SMOOTHLY AND THE PATIENT WAS DISCHARGED. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING, INFLAMMATION AND WOUND SECRETION. FORTY-NINE DAYS AFTER SURGERY, THE WOUND DID NOT HEAL, WITH A SMALL AMOUNT OF EXUDATION AND REDNESS. DUE TO POOR WOUND HEALING AFTER SURGERY, THE PATIENT WAS READMITTED FOR DEBRIDEMENT AND DRESSING CHANGE AND ANCHOR NAIL REMOVAL AND ANTI-INFECTION TREATMENT. THE SECOND SURGERY WAS A DEBRIDEMENT AND INTERNAL FIXATION REMOVAL SURGERY. THE RELEVANT DEPARTMENTS WERE ASKED TO CONSULT BEFORE FURTHER OPERATION. FIFTY-FIVE DAYS AFTER THE FIRST SURGERY, THE WOUND WAS WELL BANDAGED, DRY, AND HAD NO EXUDATION. AFTER DISCHARGE, THE WOUND CONTINUED TO UNDERGO REGULAR DRESSING CHANGES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Impaired Healing; Inflammation

  MAUDE report 25112022 ↗
• MalfunctionMar 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE PULLED OFF. THE PROCEDURE ENDED, WITHOUT CONSEQUENCE, WITH THE USE OF ANOTHER WIRE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489800 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222073 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222007 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221979 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221951 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221940 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221935 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221919 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221915 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS THE BATCH OF SUTURE 9 TIMES AND EACH TIME THE THREAD CAME OFF EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221895 ↗
• MalfunctionJan 20, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP INFLAMMATION. THE PATIENT GAVE BIRTH VAGINALLY AND EXPERIENCED PERINEAL TEARS DURING THE DELIVERY PROCESS. THE WOUND WAS SUTURED COSMETICALLY WITH SUTURE (INTRADERMALLY SUTURE) AND THE SUTURING PROCESS WENT SMOOTHLY. THE PATIENT BEGAN TO EXPERIENCE PERINEAL PAIN 12 DAYS AFTER SURGERY, AND UPON EXAMINATION, IT WAS FOUND THAT THE INTRADERMAL SUTURE WAS EXPOSED. AFTER REMOVING THE SUTURE, THE PATIENT'S SYMPTOMS IMPROVED. 25 DAYS AFTER SURGERY, THE PATIENT FOUND THAT THE SUTURE HAD BEEN DISCHARGED AGAIN, AND THE PERINEAL WOUND WAS RED WITH PAIN AND DISCOMFORT. AFTER REMOVING SOME VISIBLE SUTURES, THE PATIENT'S PAIN SYMPTOMS WERE SIGNIFICANTLY RELIEVED. THE WOUND HEALED AS SCHEDULED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Pain

  MAUDE report 24118352 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975729 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975724 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975713 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975708 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975698 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975694 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975692 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975691 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975673 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025 AND REPORTED AT 11:50 AM. EVERY SUTURE FROM THE BOX KEPT BREAKING DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975664 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE CONTINUOUS SUTURING PROCESS OF PERINEAL LACERATION, THE SUTURE AT THE NEEDLE EMBEDDING END BROKE AND CANNOT BE USED ANYMORE. IMMEDIATELY USE NEW SUTURE TO SUTURE THE PATIENT, RESULTING IN A SECOND SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974487 ↗
• MalfunctionNov 25, 2025Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING WOUND CLOSURE (FATTY LAYER) THE SUTURE FRAYED AND SEPARATED FROM THE THREAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647792 ↗

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