Hemashield M00202175430P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00384401018254), received between Jan 26, 2017 and Mar 19, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 reports).

20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE CUSTOMER OPENED THE HEMASHIELD PLATINUM GRAFT FOR A CASE, HE WASN'T COMFORTABLE USING THE PRODUCT BECAUSE IT LOOKED DIFFERENT IN COLOR THAN THEY ARE USED TO. THEY PUT IT ASIDE AND USED A DIFFERENT GRAFT THAT THEY STATED WAS MORE WHITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640182 ↗
• MalfunctionJul 23, 2021Product Quality Problem; Product Quality Problem

  SEE INITIAL MFG REPORT NUMBER: 1640201-2021-00025. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221792 ↗
• InjuryOct 18, 2019Material Frayed; Material Frayed

  THE GRAFT WAS VERIFIED BEFORE USE AND IT WAS FOUND TO BE UNRAVELLING. CUSTOMER USED A DIFFERENT UNIT TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED.

  Patient problems: No Information

  MAUDE report 9211520 ↗
• InjurySep 19, 2019Material Frayed; Material Frayed

  THE GRAFT WAS VERIFIED BEFORE USE AND IT WAS FOUND TO BE UNRAVELING. CUSTOMER USED A DIFFERENT UNIT TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED.

  Patient problems: No Information

  MAUDE report 9087559 ↗
• MalfunctionSep 6, 2019Material Frayed; Material Frayed

  WHEN THE SURGEON CUT THE GRAFT WITH SCISSORS, THE GRAFT FRAYED. A PICTURE OF THE GRAFT WAS PROVIDED BY THE USER, SHOWING THREADS ON THE END OF THE GRAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8968672 ↗
• MalfunctionJan 26, 2017Material Frayed; Material Frayed

  DURING A VASCULAR PROCEDURE PERFORMED ON (B)(6) 2016, IT WAS REPORTED THAT THE GRAFT FRAYED AFTER TRIMMING IT AND BEGINNING THE SUTURE. THE PORTION OF THE FRAYED GRAFT WAS TRIMMED AND THE ANASTOMOSIS WAS SUCCESSFULLY COMPLETED. NO ADVERSE EFFECT FOR THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278798 ↗

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-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-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-1880-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - 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-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-1881-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• 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
• 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-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-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-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-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-1882-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• 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-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

…and 5 more.