Coated VICRYL VCPB340HRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031056398), received between Nov 25, 2019 and Jun 23, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING SPINAL SURGERY. THE PRODUCT HAS ALREADY BEEN DISCARDED, AND THE LOT NUMBER IS UNKNOWN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592609 ↗
• MalfunctionJul 29, 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, AT 12:20, WHEN SUTURE WAS USED TO SUTURE THE UTERUS, THE NEEDLE PULL OFF ISSUE HAPPENED AFTER ONE STITCH, AND A NEW SUTURE WAS USED TO SEW THE UTERUS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644639 ↗
• MalfunctionJul 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY FOR CEPHALOPELVIC DISPROPORTION DUE TO GRAVIDA 1, PARA 0, GRAVIDA 39 + 4 LOA LIVE FETUS. DURING THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING THE LOWER UTERINE INCISION. THE NEW SUTURE WAS IMMEDIATELY REPLACED. THE SURGERY WENT SMOOTHLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637876 ↗
• MalfunctionMar 7, 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. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543670 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT WAS HOSPITALIZED FOR DELIVERY DUE TO PREGNANCY. ON THE SECOND DAY OF HOSPITALIZATION, THE PATIENT UNDERWENT SURGERY. DURING THE PROCEDURE, WHEN THE DOCTOR WAS SUTURING THE UTERUS, THE SUTURE BROKE AND WAS IMMEDIATELY STOPPED FROM USE. A NEW SUTURE OF THE SAME ORIGIN, MODEL, AND BATCH WAS REPLACED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268076 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. WHEN THE DOCTOR SUTURED THE BLADDER RETROPERITONEUM, THE SUTURE BROKE. REPLACED WITH NEW SUTURE OF THE SAME ORIGIN, MODEL, AND BATCH NUMBER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759719 ↗
• MalfunctionFeb 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF CALCANEAL INTERNAL FIXATION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHEN THE DOCTOR TOOK OUT SUTURE , THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED AND CAUSED THE SUTURE TO BE UNUSABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686277 ↗
• MalfunctionJan 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN SUTURING THE UTERUS. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577023 ↗
• MalfunctionJan 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION DUE TO UMBILICAL CORD PROLAPSE AT 39 WEEKS OF PREGNANCY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR SUTURED THE LOWER SEGMENT OF THE UTERUS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563171 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. WHILE PERFORMING SURGERY ON A PATIENT, THE NURSE DISCOVERED THAT THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED WHILE PREPARING TO CLAMP THE NEEDLE WITH A NEEDLE HOLDER. CHANGED TO 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 17300135 ↗
• MalfunctionJan 25, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER OPENING THE PACKAGE, THERE WAS ONE VCP711 IN THE BOX OF VCPB340H. OTHER PACKS WERE VCPB340H. THE PRODUCT NUMBER OF THE BOX IN JAPAN IS VCPB340H AND IT IS SOLD AS A KIT IN JAPAN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241553 ↗
• MalfunctionApr 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. A NEW SUTURE WAS REPLACED IMMEDIATELY. THE DOCTOR WAS A SENIOR DOCTOR, AND THE OPERATION WAS CARRIED OUT SMOOTHLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14026942 ↗
• MalfunctionMar 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SEWING THE UTERUS DURING THE SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715164 ↗
• MalfunctionDec 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SUTURE WAS USED TO SUTURE THE UTERINE INCISION DURING THE OPERATION. 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 13002997 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE WHEN SEWING. A LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168056 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SEWING. CHANGED 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 11148524 ↗
• MalfunctionDec 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT THEIR SECOND CESAREAN SECTION SURGERY ON (B)(6) AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED. THE PROCEDURE WAS COMPLETED USING A NEW LIKE DEVICE AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10986267 ↗
• MalfunctionDec 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963364 ↗
• MalfunctionApr 23, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2020 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING THE LAYERS OF THE UTERUS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992767 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT ONE-FIFTH FROM THE NEEDLE TIP DURING USE. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857517 ↗
• MalfunctionDec 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE PULLING OFF SUTURE NEEDLE HAPPENED WHEN SEWING THE UTERUS DURING THE PROCEDURE. 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 9482239 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE TIP(DISTAL SITE. ABOUT 1MM) WAS BROKEN. UPON X-RAY, THE NEEDLE PIECE WAS NOT FOUND IN THE PATIENT'S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368753 ↗

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