Hemashield M00202175830P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401018582), received between Apr 8, 2020 and Jun 27, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT WHILE PREPARING FOR AORTIC ARCH REPLACEMENT SURGERY, A DISCOLORED PART OF COLLAGEN MELTED IN THE PRODUCT WAS FOUND. THE SURGERY WAS COMPLETED WITH THE SAME MODEL STORED IN THE HOSPITAL. THE DEFECT WAS DETECTED DURING CUTTING THE PRODUCT. THE SURGERY WAS NOT DELAYED. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14826940 ↗
• MalfunctionJun 4, 2021Inaccurate Information; Inaccurate Information

  SEE INITIAL MFR REPORT 1640201-2021-00019. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938687 ↗
• MalfunctionApr 8, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  SEE INITIAL MFR REPORTS # 1640201-2020-0008 AND # 1640201-2020-00010 COMPLAINT # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941478 ↗
• MalfunctionApr 8, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  (B)(4): THE PRODUCT WAS OPENED TO USE DURING SURGERY AND HAIR WAS FOUND IN THE PRODUCT. THE SURGERY WAS FINISHED WITH A NEW PRODUCT OF THE SAME MODEL THAT HE HAD. THE PRODUCT CAN BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938750 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 5 more.