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Hemashield M002020851260Recalls & reported problems

Intervascular Sas · Hemashield Gold Knitted Microvel Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401017684), received between Mar 1, 2019 and Jun 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (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

Device problems

  • Flaked1
  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

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

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

    IT WAS REPORTED THAT THE GRAFT INSIDE THE PRODUCT BOX DID NOT MATCH THE BOX LABELING. THE PRODUCT WAS NEVER OPENED OR IMPLANTED.

    Patient problems: No Patient Involvement

    MAUDE report 8707774 ↗
  • MalfunctionMar 1, 2019Flaked; Flaked

    TWO VASCULAR GRAFTS WERE SUTURED TOGETHER AND WERE USED ON THE SAME PATIENT (SEE MANUFACTURER REPORT 1640201-2019-00013 FOR THE OTHER INVOLVED DEVICE). WHEN SUTURING THE GRAFTS TO BE IMPLANTED, IT WAS NOTICED THAT THE COLLAGEN COATING WAS CRUMBLING LIKE BREAD CRUMBS. THE SURGEON WET THE GRAFTS WITH STERILE SALINE AND NO MORE CRUMBLING WAS NOTICED. THE GRAFTS WERE IMPLANTED IN THE ABDOMINAL AREA WITH NO OTHER SIGNS OF ISSUES OR COMPLICATIONS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8382221 ↗

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.

Other Graft, Vascular, Synthetic/Biologic Composite devices

All Graft, Vascular, Synthetic/Biologic Composite devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.