Vascufil 88864710-11VRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521101906), received between Aug 23, 2017 and Apr 26, 2021 — classified as 1 injury, 1 malfunction.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN VASCULAR ANASTOMOSIS, THE SUTURE BROKE DOWN. VASCULAR ANASTOMOSIS FAILED SO THE SURGEON USED ANOTHER PRODUCT TO COMPLETE THE CASE.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 11729662 ↗
• MalfunctionAug 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: DURING AN OPEN CABG PROCEDURE AT THE PROXIMAL ANASTOMOSIS, THE NEEDLE POPPED OFF OF THE THREAD. TO COMPLETE THE CASE ANOTHER SUTURE WAS USED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6814151 ↗

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