Vascufil 88864704-11VRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521101845), received between Jul 30, 2018 and Apr 7, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K990952); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CAROTID RECONSTRUCTION, THE NEEDLE OF THE DEVICE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048722 ↗
• MalfunctionMar 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SEWING IN BOVINE PATCHES OR VASCULAR SEAMS, THE NEEDLE BROKE INTO PIECES AND FELL ON THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE PIECES AND THERE WAS NO RESIDUES OF THE NEEDLE ON THE PATIENT DUE TO THE ISSUE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. IT WAS NOTED THAT THE SURGERY GOT EXTENDED BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941382 ↗
• MalfunctionMar 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE OFF WHEN SEWING IN BOVINE PATCHES OR VASCULAR SEAMS. THE BROKEN NEEDLE FELL INTO THE PATIENT'S BODY AND WAS ABLE TO RETRIEVED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. IT WAS NOTED THAT THE SURGICAL TIME GOT EXTENDED BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935036 ↗
• MalfunctionMar 28, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SURGERY, THE NEEDLE BROKE INTO PIECES AND FELL ON THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE PIECES AND THERE WERE NO RESIDUES OF THE NEEDLE ON THE PATIENT DUE TO THE ISSUE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN THE SURGICAL TIME DUE TO DEVICE PERFORMANCE BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934124 ↗
• MalfunctionJul 30, 2018Break

  ACCORDING TO THE REPORTER, DURING THE OPEN CONGENITAL HEART PROCEDURE, AFTER 3 HOURS DURING THE ANASTOMOSES, THE THREAD BROKE. THE INCISION WAS EXTENDED DUE TO THE PRODUCT ISSUE. AN ALTERNATIVE PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731960 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990952. One submission often covers many models, so check the product and lot details in each record.

• Z-1181-2023 · Dec 2, 2022 · Open, Classified
  Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 8
• Z-1175-2023 · Dec 2, 2022 · Open, Classified
  Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8