Hemashield M002020851270Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401017691), received between Jan 18, 2019 and Jan 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  STAFF OPENED THE BOX AND NOTICED THAT THE GRAFT INSIDE DID NOT MATCH THE BOX LABELING. THEY THOUGHT THEY WERE OPENING A GRAFT WHOSE DIMENSIONS WERE 12MMX7MMX40CM, INSTEAD THEY FOUND A GRAFT WHOSE DIMENSIONS WERE 14MMX7MMX40CM. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED. IT WAS REPORTED THAT THE EVENT OCCURRED SOME TIME AGO BUT THERE WAS A REPORTING OMISSION. THE EVENT DATE IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8260461 ↗

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-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-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-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-2066-2010 · May 24, 2010 · Terminated
  Hemashield Gold Woven and Knitted Double Vascular Grafts.