Coated VICRYL VCP519HRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031054066), received between Mar 27, 2019 and Mar 4, 2025 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC SURGERY ON AN UNKNOWN DATE IN 2025 AND SUTURE WAS USED. THE NEEDLE COMES OFF THE THREAD DURING SURGERY. NO CASUALTIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513581 ↗
• MalfunctionMar 4, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC SURGERY ON AN UNKNOWN DATE IN 2025 AND SUTURE WAS USED. THE NEEDLE COMES OFF THE THREAD DURING SURGERY. NO CASUALTIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513578 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROSTHESIS ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INFECTION OF THE THREAD OF THE SUB SKIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 21054541 ↗
• InjuryJan 2, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROSTHESIS ON AN UNKNOWN DATE AND SUTURE WAS USED. AT THE 6 WEEK POST-OP CONSULTATION, THERE WERE SIGNS OF INFECTION. THE PATIENT UNDERWENT A REPROGRAMMING OF A PROSTHESIS WASH TO THE BLOCK. DURING THE PROCEDURE, IT WAS DISCOVERED AN INFECTION OF THE THREAD OF SUB SKIN. ACCORDING TO SURGEON, ALREADY ARRIVED SEVERAL TIMES PROSTHESIS INFECTIONS RESUMED IN THE OPERATING ROOM ON (B)(6) 2024. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 21054539 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A C-SECTION WAS BEING PERFORMED AND THE SURGEON NOTED THAT THE NEEDLE SEEMED VERY BLUNT. UPON INSPECTION IT WAS NOTED THAT THE VERY TIP HAD SNAPPED OFF IN THE PATIENT. THE TEAM COULD NOT FIND THE TIP. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939472 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES BROKE MID SUTURING AND REQUIRED A PORTABLE X-RAY TO LOCATE THE MISSING HALF ON A PATIENT IN DELIVERY SUITE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19559311 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES BROKE MID SUTURING AND REQUIRED A PORTABLE X-RAY TO LOCATE THE MISSING HALF ON A PATIENT IN DELIVERY SUITE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559309 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION IN (B)(6) 2021 AND SUTURE WAS USED. THE PATIENT DEVELOPED AN ALLERGIC REACTION (SKIN RASH). QUESTIONABLE PATIENT DAMAGE, ALLEGEDLY PERMANENT SKIN RASH IN THE ABDOMEN AND THIGHS. ALL MATERIALS USED (DESINFECTION, BANDAGES, OINTMENTS, MEDICATION, ETC.) WILL BE ANALYZED FOR ALLERGY-CAUSING INGREDIENTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16230590 ↗
• MalfunctionDec 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE RECTUS SHEATH. DURING THE PROCEDURE, WHILE SUTURING RECTUS SHEATH, THE SUTURE SNAPPED OFF THE NEEDLE. THE PROCEDURE WAS DELAYED BY 2 MINUTES, HOWEVER, IT WAS STATED THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035562 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE AWAY FROM THE NEEDLE WHILE SUTURING THE KNEE ARTHROTOMY. THE PROCEDURE WAS DELAYED BY 5 MINUTES, A NEW SUTURE WAS OPENED, AND THE CLOSURE RESTARTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522236 ↗
• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE SUTURING. PIECES REMAINED INSIDE ABDOMEN OF THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14192229 ↗
• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE SUTURING. PIECES REMAINED INSIDE ABDOMEN OF THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14192225 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DURING SURGICAL PROCEDURE DURING GOING THROUGH THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869893 ↗
• MalfunctionJun 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE AT THE SWAGE WITH MINIMAL PULL-FORCE. THE PROCEDURE WAS FINISHED WITH LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667531 ↗
• MalfunctionJun 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE AT THE SWAGE WITH MINIMAL PULL-FORCE. THE PROCEDURE WAS FINISHED WITH LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667529 ↗
• MalfunctionJun 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE AT THE SWAGE WITH MINIMAL PULL-FORCE. THE PROCEDURE WAS FINISHED WITH LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667528 ↗
• MalfunctionJun 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE AT THE SWAGE WITH MINIMAL PULL-FORCE. THE PROCEDURE WAS FINISHED WITH LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667527 ↗
• MalfunctionApr 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE SWAGE END CAME AWAY FROM THE NEEDLE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480400 ↗
• MalfunctionApr 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE SWAGE END CAME AWAY FROM THE NEEDLE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480377 ↗
• MalfunctionApr 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE SWAGE END CAME AWAY FROM THE NEEDLE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480352 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING THE CLOSURE THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458744 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING THE CLOSURE THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458737 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING THE CLOSURE THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458733 ↗

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