Hemashield M00202175410P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401018322), received between May 7, 2021 and Oct 13, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• InjuryOct 13, 2022Flaked; Flaked

  IT WAS REPORTING TO INTERVASCULAR THAT DURING SURGERY, THE SURGEON USED A HEMASHIELD PLATINUM WOVEN STRAIGHT. THE PRODUCT WAS IMPLANTED WITHOUT ANY PRIOR TRIMMING. WHILE SUTURING THE ANASTOMOSIS WITH PROLENE SUTURE, THE GRAFT BEGAN TO FRAY OR « UNRAVEL ». THE SURGEON CUT DOWN A LITTLE FURTHER ON THE GRAFT TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS AND THE SURGERY WAS NOT DELAYED COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597055 ↗
• InjuryOct 7, 2022Flaked; Flaked

  IT WAS REPORTING TO INTERVASCULAR THAT DURING SURGERY, THE SURGEON USED A HEMASHIELD PLATINUM WOVEN STRAIGHT. THE PRODUCT WAS IMPLANTED WITHOUT ANY PRIOR TRIMMING. WHILE SUTURING THE ANASTOMOSIS WITH PROLENE SUTURE, THE GRAFT BEGAN TO FRAY OR UNRAVEL. THE SURGEON CUT DOWN A LITTLE FURTHER ON THE GRAFT TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS AND THE SURGERY WAS NOT DELAYED. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15560378 ↗
• MalfunctionMay 7, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  AT GOODS RECEIPT, DURING INCOMING INSPECTION PERFORMED BY THE CUSTOMER (DISTRIBUTOR), THREE PRODUCTS M00202175410P0 WERE REFUSED DUE TO A DAMAGE ON THE PRODUCT BOX. HOWEVER, THE SHIPPING CARTON WAS INTACT. COMPLAINT # (B)(4). THIS MDR IS PART OF A SERIES OF THREE MDRS INVOLVING THE THREE NONCONFORMING PRODUCTS (SERIAL NUMBERS (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788878 ↗
• MalfunctionMay 7, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  AT GOODS RECEIPT, DURING INCOMING INSPECTION PERFORMED BY THE CUSTOMER (DISTRIBUTOR), THREE PRODUCTS M00202175410P0 WERE REFUSED DUE TO A DAMAGE ON THE PRODUCT BOX. HOWEVER, THE SHIPPING CARTON WAS INTACT. COMPLAINT # (B)(4). THIS MDR IS PART OF A SERIES OF THREE MDRS INVOLVING THE THREE NONCONFORMING PRODUCTS (SERIAL NUMBERS (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788877 ↗
• MalfunctionMay 7, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  AT GOODS RECEIPT, DURING INCOMING INSPECTION PERFORMED BY THE CUSTOMER (DISTRIBUTOR), THREE PRODUCTS (B)(4) WERE REFUSED DUE TO A DAMAGE ON THE PRODUCT BOX. HOWEVER, THE SHIPPING CARTON WAS INTACT. COMPLAINT # (B)(4). THIS MDR IS PART OF A SERIES OF THREE MDRS INVOLVING THE THREE NONCONFORMING PRODUCTS. (SERIAL NUMBERS (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788876 ↗

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

…and 5 more.