Hemashield M00202166168P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401018452), received between Dec 7, 2018 and May 6, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

1 FDA recall record name this device's identifier.

19 other recalls cover devices cleared under the same FDA submission (K021213); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Aug 22, 2019Terminated

   Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).

   Z-2559-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO INTERVASCULAR THAT A PATIENT WAS PRESENTING WITH RECURRENT PERIPROSTHETIC PURULENT COLLECTIONS, WHICH WERE STERILE AFTER CULTURE. GIVEN THE RECURRENCE OF THESE EVENTS, A HYPERSENSITIVITY REACTION TO VASCULAR PROSTHESES HAS BEEN SUGGESTED BY THE HOSPITAL. THE PATIENT HAS THREE PROSTHESES MANUFACTURED BY INTERVESCULAR: ONE HEMASHIELD PRODUCT WHICH IS THE SUBJECT OF THIS REPORT. -THE TWO OTHER DEVICES ARE INTERGARD SILVER GRAFTS. COMPLAINT # (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21970615 ↗
• InjuryApr 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO INTERVASCULAR THAT A PATIENT WAS PRESENTING WITH RECURRENT PERIPROSTHETIC PURULENT COLLECTIONS, WHICH WERE STERILE AFTER CULTURE. GIVEN THE RECURRENCE OF THESE EVENTS, A HYPERSENSITIVITY REACTION TO VASCULAR PROSTHESES HAS BEEN SUGGESTED BY THE HOSPITAL. THE PATIENT HAS THREE PROSTHESES MANUFACTURED BY INTERVESICULAR: - ONE HEMASHIELD PRODUCT WHICH IS THE SUBJECT OF THIS REPORT. - THE TWO OTHER DEVICES ARE INTERGARD SILVER GRAFTS. COMPLAINT #(B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21924372 ↗
• InjuryDec 7, 2018Material Puncture/Hole; Material Puncture/Hole

  DURING SURGERY, A HOLE WAS IDENTIFIED AT THE CROTCH OF THE BIFURCATED GRAFT. THE SURGEON SEWED THE GRAFT HOLE IN ORDER TO STOP THE BLEEDING. PATIENT WAS ENDANGERED BUT NOT INJURED.

  Patient problems: Blood Loss

  MAUDE report 8142266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021213. One submission often covers many models, so check the product and lot details in each record.

• Z-1864-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected wit
• Z-1876-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1873-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1878-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1871-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1868-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1879-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1867-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1875-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1874-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1865-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected wit
• Z-1869-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1870-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1866-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1877-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury

…and 4 more.