Coated VICRYL VCP315H (UDI 10705031052215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031052215), received between Jul 26, 2019 and Jul 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PARTIAL NEPHRECTOMY ON (B)(6) 2017 AND SUTURE WAS USED. DURING THE PROCEDURE, A SURGICAL NEEDLE WAS INADVERTENTLY RETAINED. THE PATIENT HAD A TOMOGRAPHY/CT SCANS PERFORMED IN 2018 AND 2020 WHICH CONFIRMED THE PRESENCE OF A CURVED METAL STRUCTURE (HALF-MOON SHAPE), RADIOPAQUE, WITH ABOUT 2.5 CM IN THE LARGEST AXIS, HOUSED NEAR THE LOWER POLE OF THE RIGHT KIDNEY AND ENCAPSULATED BY FIBROSIS, WITHOUT MOBILITY. FROM THE LIST OF MATERIALS USED IN THE SURGERY, THE NEEDLE CORRESPONDS, WITH A HIGH PROBABILITY, TO THE CT-1 NEEDLE. THE PATIENT CURRENTLY NEEDS TO CHECK IF SHE CAN HAVE AN MRI SCAN SAFELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25689954 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL REPAIR FOLLOWING A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF INSIDE THE TISSUE OF THE VAGINA. PATIENT WAS PALPATED TILL THE PATIENT COULD FEEL THE NEEDLE THEN THE SURGEON DUG AROUND IN THAT AREA TILL THE NEEDLE WAS FOUND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941360 ↗
• MalfunctionJul 26, 2019Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE FELL WHILE USING IT IN THE CAVITY. THE THREAD WAS FRAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833230 ↗

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