Coated VICRYL VCP364HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031052772), received between Jun 13, 2019 and Mar 15, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, 4 SUTURES GOT DETACHED FROM THE SWAGE END OF THE NEEDLES DURING CAESAREAN SECTION. ANOTHER SUTURE FROM THE SAME LOT BROKE DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771700 ↗
• MalfunctionMar 15, 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, 4 SUTURES GOT DETACHED FROM THE SWAGE END OF THE NEEDLES DURING CAESAREAN SECTION. ANOTHER SUTURE FROM THE SAME LOT BROKE DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771695 ↗
• MalfunctionMar 15, 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, 4 SUTURES GOT DETACHED FROM THE SWAGE END OF THE NEEDLES DURING CAESAREAN SECTION. ANOTHER SUTURE FROM THE SAME LOT BROKE DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771691 ↗
• MalfunctionMar 15, 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, 4 SUTURES GOT DETACHED FROM THE SWAGE END OF THE NEEDLES DURING CAESAREAN SECTION. ANOTHER SUTURE FROM THE SAME LOT BROKE DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771689 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE NEEDLE APPEARED BLUNT. WHEN EXAMINED CLOSELY, THE TIP OF THE BLUNT NEEDLE DOES NOT LOOK JIGGERED OR DAMAGED - BLUNT TO TOUCH. THE NEEDLE WAS USED ON THE PATIENT. THE TIP WAS NOT VISUALLY INSPECTED PRIOR TO USE WHEN USED. THE SURGEON COMPLAINED OF BLUNT FEEL WHILE PUSHING THROUGH THE TISSUE. AN X-RAY TAKEN ON OPERATING TABLE TO EXCLUDE TIP BEING LEFT IN WOUND AND UNABLE TO SEE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. UPON EVALUATION OF THE RETURNED DEVICE, A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567546 ↗
• MalfunctionJul 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791027 ↗
• MalfunctionJul 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791000 ↗
• MalfunctionJun 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD WAS FOUND DETACHED FROM THE NEEDLE WHEN REPAIRING THE UTERUS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701282 ↗
• MalfunctionJun 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE WHEN REPAIRING THE UTERUS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701253 ↗
• MalfunctionJun 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE WHEN REPAIRING THE UTERUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING ANOTHER NEW PACK OF SUTURE TO CONTINUE THE WOUND CLOSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697299 ↗
• MalfunctionJun 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE WHEN REPAIRING THE UTERUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING ANOTHER NEW PACK OF SUTURE TO CONTINUE THE WOUND CLOSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697290 ↗

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