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Hemashield M002020852210Recalls & reported problems

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

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401017790), received between Sep 14, 2021 and Jan 20, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (4 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

Device problems

  • Nonstandard Device4

Patient problems

  • Hemorrhage/Blood Loss/Bleeding4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 20, 2022Nonstandard Device; Nonstandard Device

    PROBLEM: BLOOD LEAKS FROM THE CROTCH OF THE Y TUBE. AN ADDITIONAL ANASTOMOSIS IS PERFORMED ON THE ARTIFICIAL BLOOD VESSEL, LEADING TO HEMOSTASIS. AS OF SEPTEMBER, THE HOSPITAL DID NOT REPORT ANY PROBLEMS TO THE DISTRIBUTOR. COMPLAINT # (B)(4).

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13307285 ↗
  • InjuryJan 18, 2022Nonstandard Device; Nonstandard Device

    (B)(4).

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13277936 ↗
  • InjurySep 16, 2021Nonstandard Device; Nonstandard Device

    COMPLAINT #(B)(4). SEE MFG REPORT(S) 1640201-2021-00030.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 12480388 ↗
  • InjurySep 14, 2021Nonstandard Device; Nonstandard Device

    COMPLAINT # (B)(4), SEE MFG REPORT(S) 1640201-2021-00030.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 12467505 ↗

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-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-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.