Coated VICRYL VCP683HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031054769), received between Apr 18, 2018 and Apr 12, 2019 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Extrusion” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAD BEEN DETACHING FROM THE SUTURE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511176 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472926 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472897 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472757 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472742 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472717 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472681 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472615 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472598 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472580 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472556 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472504 ↗
• InjuryApr 30, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7472489 ↗
• InjuryApr 18, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7439784 ↗
• InjuryApr 18, 2018Extrusion; Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND IRRITATION IN THE SUTURE AREA. LOCAL REDNESS OF THE SEAM WAS NOTED, WITHOUT PUS. IN SOME PLACES THERE WERE AREAS OF COMPACTION WITH BUBBLES, AFTER OPENING WHICH SMALL GRANULES WERE SEPARATED WITH PIECE OF DEFRAGMENTED PRODUCT. THE REMAINING THREAD WAS REMOVED FROM DIFFERENT ENDS OF THE SEAM. THE WOUND WAS CLEANED AND SUTURE WAS USED ON THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Not Applicable; Pain; Reaction

  MAUDE report 7439782 ↗

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