Hemashield M002020951080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401017363), received between Apr 15, 2016 and Feb 6, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K954848); 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 6, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A CARDIAC SURGERY PERFORMED ON (B)(6) 2017, THE INVOLVED GRAFT WAS USED TO CANNULATE THE AXILLARY ARTERY FOR CARDIOPULMONARY BYPASS. THE GRAFT WAS SOAKED WITH RIFAMPICIN BEFORE THE CASE FOR ABOUT 10 MINUTES. IT WAS REPORTED THAT EXCESSIVE WEEPING/BLEEDING THROUGH THE GRAFT WAS NOTICED DURING THE PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 6303630 ↗
• InjuryApr 15, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING SURGERY PERFORMED ON (B)(6) 2016, THE GRAFT WAS USED AS A CONDUIT FOR A BYPASS FOR AORTIC ROOT REPLACEMENT. THE GRAFT WAS REPORTED TO WEEP, AND SURGICAL GLUE WAS USED TO STOP THE WEEPING. NO ADDITIONAL INFORMATION COULD BE OBTAINED AT THE DATE OF THIS REPORT.

  Patient problems: Blood Loss

  MAUDE report 5580347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954848. One submission often covers many models, so check the product and lot details in each record.

• Z-0729-2022 · Jan 14, 2022 · Terminated
  HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive
• Z-0403-2022 · Dec 1, 2021 · Terminated
  Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
• Z-1859-2020 · Apr 7, 2020 · Terminated
  Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affect
• Z-1861-2020 · Apr 7, 2020 · Terminated
  Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affect
• Z-1860-2020 · Apr 7, 2020 · Terminated
  Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affect
• Z-2066-2010 · May 24, 2010 · Terminated
  Hemashield Gold Woven and Knitted Double Vascular Grafts.