Hemashield M002020851890Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401017752), received between Nov 13, 2023 and Nov 15, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

1 FDA recall record name this device's identifier.

5 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.

Recalls naming this device

1. Dec 1, 2021Terminated

   There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

   Z-0403-2022 · Root cause: Labeling Change Control · FDA record ↗

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.

• InjuryNov 15, 2023Material Puncture/Hole; Material Puncture/Hole

  COMPLAINT #(B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140157 ↗
• InjuryNov 13, 2023Material Puncture/Hole; Material Puncture/Hole

  COMPLAINT # (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117729 ↗

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-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.