Hemashield M00202175132P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401018094), received between Feb 6, 2018 and Oct 10, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2022Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571559 ↗
• InjuryJul 21, 2020Material Frayed; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Frayed; Product Quality Problem; Improper or Incorrect Procedure or Method

  SEE INITIAL MFR REPORT # 1640201-2020-00018. COMPLAINT#: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305418 ↗
• InjuryJul 21, 2020Material Frayed; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Frayed; Product Quality Problem; Improper or Incorrect Procedure or Method

  THE VASCULAR GRAFT SHOWED A STRONG FRAYING AFTER CUTTING WITH POTTS SCISSOR. THE GRAFT WAS THEN IMPLANTED AFTER CLEANING OF THE CUT EDGE TO REMOVE PARTICLES. THE SURGERY WAS JUST A FEW MINUTES DELAYED IN RELATION WITH THE CLEANING OF THE CUT EDGE. NO HARM TO PATIENT WAS REPORTED UNTIL TODAY. THE NON-IMPLANTED PART IS AVAILABLE FOR INSPECTION. THE CUSTOMER ALWAYS CUTS PROSTHESIS WITH SCISSORS. THE CUSTOMER HAS BEEN SWITCHED FROM COMPETITORS TO GETINGE HEMASHIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302551 ↗
• MalfunctionJul 17, 2020Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  SEE INITIAL MFR REPORT # 1640201-2020-00016. COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10289429 ↗
• MalfunctionFeb 6, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED BY THE HOSPITAL TWO CASES WERE THE DEVICES WERE FOUND WITH NO LABEL FOR DOCUMENTATION AND NO DIRECTION FOR USE IN THE PACKAGING. THE DEVICES WERE USED WITHOUT ANY CONSEQUENCE FOR PATIENTS. THE SECOND CASE IS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 1640201-2018-00003.

  Patient problems: Not Applicable

  MAUDE report 7243513 ↗

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

…and 5 more.