Coated VICRYL VCPB945HRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705031056701), received between Sep 12, 2019 and Aug 25, 2026 — classified as 5 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Material Separation” (22 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441141 ↗
• MalfunctionMay 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 8:20 AM, AFTER THE MOTHER GAVE BIRTH NATURALLY, THE MIDWIFE PREPARED TO SUTURE 1-DEGREE LACERATION PERINEUM. AFTER UNPACKING THE SUTURE PACKAGING, IT WAS FOUND THAT THE NEEDLE PULL OFF ISSUE HAD HAPPENED. IT WAS IMMEDIATELY STOPPED FROM USE AND KEPT. AFTER REPLACING WITH ANOTHER SUTURE, IT WAS USED NORMALLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127766 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY DURING USE ON THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850589 ↗
• InjuryDec 19, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT ROUTINE SUTURING DUE TO A PERINEAL AND VAGINAL LACERATION AFTER DELIVERY. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING. ON THE SECOND DAY AFTER SURGERY, THE PATIENT EXPERIENCED SIGNIFICANT PAIN IN THE PERINEUM (UNCERTAIN WHETHER IT WAS CAUSED BY THE SUTURE, USUALLY IN THE FIRST FEW DAYS AFTER DELIVERY). PHYSICAL EXAMINATION SHOWED THAT THE EXTERNAL GENITAL LACERATION WAS SLIGHTLY RED, AND THE LEFT LABIA MAJORA HAD OBVIOUS TENDERNESS. AFTER CHECKING BLOOD ROUTINE AND WHOLE BLOOD C-REACTIVE PROTEIN, IT WAS CONSIDERED THAT THERE MAY BE A PERINEAL INFECTION. CEFTRIAXONE 2G, QD ANTI INFECTION TREATMENT WAS GIVEN FOR 3 DAYS. ON THE 6TH DAY AFTER SURGERY, THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN PERINEAL PAIN, SLIGHT SWELLING, AND NO FEVER. THE PATIENT WAS DISCHARGED ON THE 6TH DAY AFTER SURGERY. ON THE 9TH DAY AFTER SURGERY, THE PATIENT CAME TO THE OUTPATIENT DEPARTMENT AND COMPLAINED OF PAIN IN THE PERINEUM FOR SEVERAL DAYS. THE PATIENT WAS GIVEN A 1:1 DILUTED LIDOCAINE LOCAL ANESTHESIA ON THE EDGE OF THE PERINEUM HYMEN, AND AFTER THOR

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23849306 ↗
• InjuryDec 19, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT ROUTINE SUTURING DUE TO A PERINEAL AND VAGINAL LACERATION AFTER DELIVERY. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING. ON THE SECOND DAY AFTER SURGERY, THE PATIENT EXPERIENCED SIGNIFICANT PAIN IN THE PERINEUM (UNCERTAIN WHETHER IT WAS CAUSED BY THE SUTURE, USUALLY IN THE FIRST FEW DAYS AFTER DELIVERY). PHYSICAL EXAMINATION SHOWED THAT THE EXTERNAL GENITAL LACERATION WAS SLIGHTLY RED, AND THE LEFT LABIA MAJORA HAD OBVIOUS TENDERNESS. AFTER CHECKING BLOOD ROUTINE AND WHOLE BLOOD C-REACTIVE PROTEIN, IT WAS CONSIDERED THAT THERE MAY BE A PERINEAL INFECTION. CEFTRIAXONE 2G, QD ANTI INFECTION TREATMENT WAS GIVEN FOR 3 DAYS. ON THE 6TH DAY AFTER SURGERY, THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN PERINEAL PAIN, SLIGHT SWELLING, AND NO FEVER. THE PATIENT WAS DISCHARGED ON THE 6TH DAY AFTER SURGERY. ON THE 9TH DAY AFTER SURGERY, THE PATIENT CAME TO THE OUTPATIENT DEPARTMENT AND COMPLAINED OF PAIN IN THE PERINEUM FOR SEVERAL DAYS. THE PATIENT WAS GIVEN A 1:1 DILUTED LIDOCAINE LOCAL ANESTHESIA ON THE EDGE OF THE PERINEUM HYMEN, AND AFTER THOR

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23849305 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. 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 23840341 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. 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 23840319 ↗
• MalfunctionDec 17, 2025Material Separation; Material Separation

  PULL OFF SUTURE NEEDLE. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828289 ↗
• MalfunctionDec 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED 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 23828202 ↗
• MalfunctionDec 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED 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 23828161 ↗
• InjuryDec 11, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL EPISIOTOMY REPAIR ON (B)(6) 2025 AND SUTURE WAS USED ON THE VAGINAL MUCOSA AND PERINEAL MUSCLE LAYER. THE INTRAOPERATIVE SUTURING WAS OPERATED SMOOTHLY. ABOUT 20 DAYS AFTER SURGERY, ON (B)(6) 2025, THE PATIENT HAD PERINEAL WOUND REDNESS, SWELLING AND PAIN. AFTER EXAMINATION, THE DOCTOR FOUND THAT THE PATIENT'S PERINEAL WOUND HAD POOR HEALING AND THE SUTURE WAS NOT ABSORBED. THEREFORE, THE PATIENT WAS GIVEN PERINEAL WOUND DEBRIDEMENT AND REMOVAL OF UNABSORBED SUTURE. AFTERWARDS, THE PATIENT'S WOUND HEALING CONDITION WAS IMPROVED. NO SUBSEQUENT ADVERSE EVENT REPORTS WERE RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 23777678 ↗
• InjuryDec 10, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL EPISIOTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS USED TO SEW VAGINA DURING SURGERY. AROUND 20 DAYS AFTER PERINEAL LATERAL INCISION SURGERY, THE WOUND WAS RED AND SWOLLEN, AND THE SUTURE WAS NOT ABSORBED. REMOVED THE SUTURE AND THE PATIENT IS STABLE NOW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 23771810 ↗
• MalfunctionDec 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 23682310 ↗
• MalfunctionDec 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 23682252 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE ON ITS OWN, CAUSING THE INCISION THAT HAD ALREADY BEEN SUTURED HALFWAY TO SPLIT OPEN. AFTER THE ENTIRE SUTURE WAS REMOVED, A NEW SUTURE WAS REPLACED AND RE SUTURED. INCREASED THE DIFFICULTY AND DURATION OF THE SURGERY. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605869 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE 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 23291035 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE 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 23290749 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE 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 23290049 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE 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 23290046 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EPISIOTOMY REPAIR PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542058 ↗
• MalfunctionJun 19, 2025Defective Component; Device Contaminated During Manufacture or Shipping; Defective Component; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT'S REPORTED IT FOUND FOREIGN MATTER ON THE SUTURE SURFACE WHEN OPENING THE PACKAGE, BEFORE USING ON THE PATIENT, AND A CERTAIN PART OF SUTURE BECAME SLIM AND ALMOST TO BREAK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292666 ↗
• MalfunctionMar 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED AT 7:40, AFTER VAGINAL DELIVERY, SUTURES ARE NEEDED, AND ONCE OPENED, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED. 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 21610540 ↗
• MalfunctionDec 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 20844355 ↗
• MalfunctionNov 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 20667418 ↗
• MalfunctionSep 26, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE MOTHER GAVE BIRTH VAGINALLY IN THE DELIVERY ROOM. DUE TO A DEGREE I PERINEAL LACERATION, THE NURSE USED SUTURE TO SUTURE THE WOUND. THE PATIENT WAS DISCHARGED NORMALLY ON THE 5TH DAY AFTER SURGERY. POST OP, ON (B)(6) 2024 ON THE SEVENTH DAY AFTER DELIVERY, PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP EXAMINATION AND COMPLAINED OF PAIN IN THE WOUND. THE PATIENT ALSO CLOSELY MONITORED PERSONAL HYGIENE BUT DID NOT SEE ANY IMPROVEMENT. AFTER EXAMINATION, THE NURSE FOUND THAT THE SUTURE WAS EXPOSED, THE PERINEUM WAS CLEAN, AND THERE WAS NO ODOR. THEREFORE, SHE USED A SUTURE REMOVER TO REMOVE THE SUTURE, AND THE PERINEUM HEALED WELL, BUT THE SUTURE WAS NOT ABSORBED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Inflammation; Pain; Pocket Erosion

  MAUDE report 20314188 ↗

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