Hemashield M00202175208P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00384401018148), received between Jul 30, 2018 and Apr 17, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Off-Label Use; Off-Label Use

  COMPLAINT # (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21862556 ↗
• MalfunctionAug 25, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  SEE MFG INITIAL REPORT 1640201-2021-00028. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364781 ↗
• MalfunctionJul 2, 2021Nonstandard Device; Nonstandard Device

  WHEN THE CUSTOMER OPEN A PACKAGE WITH A GRAFT, THEY FOUND THAT THE SHAPE OF ONE END OF THE GRAFT IS NOT CIRCULAR, BUT PRESSED. THE SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER GRAFT OF THE SAME MODEL. THERE WAS NO PATIENT EFFECT REPORTED. IT WAS LATER CONFIRMED BY THE CUSTOMER THAT THE PRODUCT WAS POSITIONED CORRECTLY IN THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107939 ↗
• MalfunctionNov 8, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER HAS RECEIVED THE WET PARCEL AND HE CAN'T ACCEPT IT.

  Patient problems: No Patient Involvement

  MAUDE report 9294936 ↗
• MalfunctionJul 3, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  DURING PREPARATION FOR SURGERY FOR AN AORTIC DISSECTION, A HAIR WAS FOUND INSIDE THE PRODUCT. THE CUSTOMER FINISHED THE OPERATION WITH ANOTHER AVAILABLE PRODUCT FROM SAME LOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757537 ↗
• MalfunctionJun 18, 2019Material Frayed; Material Frayed

  DURING AN AORTIC DISSECTION PROCEDURE, WHEN THE SURGEON CUT THE GRAFT WITH SCISSORS, THE GRAFT FRAYED. A PICTURE OF THE GRAFT WAS PROVIDED BY THE USER, SHOWING A CLEARLY VISIBLE STRAND AT THE CUTTING SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707776 ↗
• InjuryMar 1, 2019Product Quality Problem; Product Quality Problem

  FOLLOWING A RETURN OF UNOPENED ORIGINAL PACKAGING GRAFTS FOR CREDIT, IT WAS REPORTED THAT SURGEONS DO NOT WANT TO USE THIS GRAFT TYPE ANYMORE SINCE THE INVOLVED GRAFT LEAKED/OOZED BLOOD WHEN IMPLANTED. THERE WAS NO INJURY TO THE PATIENT BUT EVENT DETAILS ARE UNAVAILABLE (DATE, DESCRIPTION, INCIDENT HANDLING).

  Patient problems: Blood Loss

  MAUDE report 8382786 ↗
• MalfunctionJul 30, 2018Material Twisted/Bent; Material Twisted/Bent

  BEFORE AXILLARY ANASTOMOSIS, THE SURGEON FOUND THAT THE GRAFT WAS BENT, WITH A DIFFERENT SHAPE FROM WHAT HE USED TO SEE. AFTER CUTTING THE STRANGE PART, THE SURGEON STILL FELT SOMETHING WAS WRONG. SO HE REPLACED THE CONCERNED GRAFT WITH ANOTHER SAME MODEL GRAFT.

  Patient problems: No Patient Involvement

  MAUDE report 7730552 ↗

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

…and 5 more.