Hemashield M00202175210P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00384401018155), received between Feb 9, 2018 and Dec 17, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

  COMPLAINT #(B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23827216 ↗
• InjuryJul 15, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED TO INTERVASCULAR THAT WHEN A PATIENT WAS HAVING AN IMPELLA 5.5 PUT IN AND WAS BEING CANNULATED WITH AN AXILLARY GRAFT, THE GRAFT WAS LEAKING THROUGHOUT THE WHOLE GRAFT SURFACE AND ALSO AT THE ANASTOMOSIS SITE. THE PATIENT LOST 6 LITERS OF BLOOD DURING THE EVENT. THE BLOOD WAS GATHERED WITH A CELL SAVER AND GIVEN BACK TO THE PATIENT. THE SURGEON HAD TO USE 20ML OF FLOSEAL (10ML X 2). PREVELEAK WAS ALSO USED TO HELP WITH THE BLEEDING. THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU); HOWEVER, THE PATIENT HAD TO COME BACK TO THE OPERATING ROOM (OR) FOR BLEEDING ON (B)(6) 2024.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19745396 ↗
• InjuryJul 12, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED TO INTERVASCULAR THAT WHEN A PATIENT WAS HAVING AN IMPELLA 5.5 PUT IN AND WAS BEING CANNULATED WITH AN AXILLARY GRAFT, THE GRAFT WAS LEAKING THROUGHOUT THE WHOLE GRAFT SURFACE AND ALSO AT THE ANASTOMOSIS SITE. THE PATIENT LOST 6 LITERS OF BLOOD DURING THE EVENT. THE BLOOD WAS GATHERED WITH A CELL SAVER AND GIVEN BACK TO THE PATIENT. THE SURGEON HAD TO USE 20ML OF FLOSEAL (10ML X 2). PREVELEAK WAS ALSO USED TO HELP WITH THE BLEEDING. THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU); HOWEVER, THE PATIENT HAD TO COME BACK TO THE OPERATING ROOM (OR) FOR BLEEDING ON (B)(6) 2024.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19728128 ↗
• InjuryMay 7, 2024Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem; Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO INTERVASCULAR THAT DURING AN AORTIC ANEURYSM REPAIR, AFTER THE IMPLANTATION OF THE GRAFT, BLOOD WAS LEAKING THOUGH THE GRAFT. THE GRAFT WAS WRAPPED WITH SURGICELL PRODUCT, AND THE BLEEDING STOPPED. THERE WAS NO PATIENT INJURY. THE SURGERY WAS DELAYED DUE TO TROUBLE SHOOTING AND WRAPPING SURGICELL AROUND GRAFT. PATIENT IDENTIFIERS AND MEDICAL HISTORY UNKNOWN. NO OTHER CONCOMITANT PRODUCTS USED. NO MEDICAL FOLLOW UP NEEDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19260484 ↗
• InjuryMay 3, 2024Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem; Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO INTERVASCULAR THAT DURING AN AORTIC ANEURYSM REPAIR, AFTER THE IMPLANTATION OF THE GRAFT, BLOOD WAS LEAKING THOUGH THE GRAFT. THE GRAFT WAS WRAPPED WITH SURGICELL PRODUCT, AND THE BLEEDING STOPPED. THERE WAS NO PATIENT INJURY. THE SURGERY WAS DELAYED DUE TO TROUBLE SHOOTING AND WRAPPING SURGICELL AROUND GRAFT. PATIENT IDENTIFIERS AND MEDICAL HISTORY UNKNOWN. NO OTHER CONCOMITANT PRODUCTS USED. NO MEDICAL FOLLOW UP NEEDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19236323 ↗
• InjuryOct 17, 2019Off-Label Use; Manufacturing, Packaging or Shipping Problem; Off-Label Use; Manufacturing, Packaging or Shipping Problem

  SEE INITIAL MFR REPORT 1640201-2019-00079. COMPLAINT # (B)(4).

  Patient problems: Blood Loss

  MAUDE report 9205419 ↗
• InjuryOct 8, 2019Off-Label Use; Manufacturing, Packaging or Shipping Problem; Off-Label Use; Manufacturing, Packaging or Shipping Problem

  SEE INITIAL MFR REPORT 1640201-2019-00079. COMPLAINT # (B)(4).

  Patient problems: Blood Loss

  MAUDE report 9167368 ↗
• MalfunctionFeb 9, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CASE, A (B)(4) HEMASHIELD PLATINUM WOVEN BOX WAS OPENED. THE BOX WAS INTACT AND WAS PROPERLY LABELED AND HAD THE PLASTIC TRAY INSIDE THE BOX BUT NO GRAFT.

  Patient problems: No Information

  MAUDE report 7258601 ↗

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

…and 5 more.