Coated VICRYL VCP323HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031052291), received between Aug 7, 2019 and Mar 12, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POINT BROKE INTRAOPERATIVE, WAS IDENTIFIED BECAUSE NEEDLE BECAME DULL. NO FURTHER INFORMATION AVAILABLE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590093 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE AFTER LABOR ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS PROLONGED BY 1 TO 5 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582469 ↗
• MalfunctionMay 28, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A MIDWIFE PROCEDURE ON AN UNKNOWN DATE IN 2024. THE MIDWIFE HAD TO SEW UP A RUPTURE AND ENDED UP USING SIX PACKS OF SUTURE. THEY DROVE AROUND THE NEEDLEHOLDER, TWO THREADS BROKE, AND ALSO ONE NEEDLE BROKE. THE MIDWIFE ALSO CHANGED SEWING SETS SO THAT THEY TRIED WITH BOTH A GENERAL MULTI-USE SET, AND A SINGLE-USE SET. IT DIDN'T HELP. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19406521 ↗
• MalfunctionMay 28, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A MIDWIFE PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024. THE MIDWIFE HAD TO SEW UP A RUPTURE AND ENDED UP USING SIX PACKS OF SUTURE. THEY DROVE AROUND THE NEEDLEHOLDER, TWO THREADS BROKE, AND ALSO ONE NEEDLE BROKE. THE MIDWIFE ALSO CHANGED SEWING SETS SO THAT THEY TRIED WITH BOTH A GENERAL MULTI-USE SET, AND A SINGLE-USE SET. IT DIDN'T HELP. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19405542 ↗
• MalfunctionMay 28, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A MIDWIFE PROCEDURE ON AN UNKNOWN DATE IN 2024. THE MIDWIFE HAD TO SEW UP A RUPTURE AND ENDED UP USING SIX PACKS OF SUTURE. THEY DROVE AROUND THE NEEDLE HOLDER, TWO THREADS BROKE, AND ALSO ONE NEEDLE BROKE. THE MIDWIFE ALSO CHANGED SEWING SETS SO THAT THEY TRIED WITH BOTH A GENERAL MULTI-USE SET, AND A SINGLE-USE SET. IT DIDN'T HELP. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19405502 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING WAS IN PROGRESS, THE NEEDLE BROKE. THE BROKEN PORTION OF NEEDLE WAS REMOVED FROM TISSUE AND DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13089692 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE, CAUSING THE PATIENTS' POSTPARTUM PERINEAL EDEMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Edema

  MAUDE report 10738327 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE, CAUSING THE PATIENTS' POSTPARTUM PERINEAL EDEMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Edema

  MAUDE report 10738326 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE, CAUSING THE PATIENTS' POSTPARTUM PERINEAL EDEMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Edema

  MAUDE report 10738324 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE, CAUSING THE PATIENTS' POSTPARTUM PERINEAL EDEMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Edema

  MAUDE report 10738323 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE, CAUSING THE PATIENTS' POSTPARTUM PERINEAL EDEMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Edema

  MAUDE report 10738322 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE, CAUSING THE PATIENTS' POSTPARTUM PERINEAL EDEMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Edema

  MAUDE report 10738320 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE, CAUSING THE PATIENTS' POSTPARTUM PERINEAL EDEMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Edema

  MAUDE report 10738319 ↗
• MalfunctionSep 11, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8993296 ↗
• MalfunctionSep 11, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8993291 ↗
• MalfunctionSep 11, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8993290 ↗
• MalfunctionSep 11, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE UNRAVELED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8993285 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869026 ↗

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