Coated VICRYL VCP480HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031053595), received between Aug 15, 2019 and Oct 26, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE TIP FELL OFF, AND WAS RETRIEVED. SURGEON OPENED ANOTHER PACK OF SUTURE; THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736352 ↗
• MalfunctionAug 25, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS TORN WHILE SUTURING THE DEEP DERMAL LAYER AT WOUND CLOSURE STAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449289 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE TIP BREAKAGE WAS NOTED DURING CAPSULAR ANCHORING. INTRA- OP WOUND EXPLORATION AND X-RAY SCREENING SHOWED NO CORRESPONDING NEEDLE TIP RETENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125883 ↗
• MalfunctionAug 15, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY CAESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON NOTICED THE BROKEN NEEDLE TIP ON MIDWAY OF CLOSING THE FIRST LAYER OF THE UTERUS. THE TIP WAS NOT ABLE TO BE FOUND. AN X-RAY WAS DONE BUT THE TIP WAS NOT VISIBLE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898693 ↗

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