Hemashield M00202175924P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401018636), received between Mar 28, 2019 and Dec 27, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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.

• InjuryDec 27, 2023Manufacturing, 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 THE PATIENT UNDERWENT SURGERY FOR AORTIC COARCTATION AS AN EMERGENCY SURGERY ON (B)(6) 2023. HE WAS SENT TO THE CARDIOTHORACIC SURGERY INTENSIVE CARE UNIT AFTER SURGERY FOR SUDDEN VENTRICULAR FIBRILLATION. THE PATIENT WAS GIVEN CARDIAC COMPRESSION, ELECTRIC DEFIBRILLATION AND OTHER RESUCITATION MEASURES TO RESTORE THE SINUS HEART RATE, BUT VENTRICULAR FIBRILLATION RECURRED, AND THE PATIENT'S MEDIASTINAL DRAIN FLOW SUDDENLY INCREASED, SO THE PATIENT WAS CONSIDERED TO HAVE ACTIVE TRAUMATIC BLEEDING (ABOUT 500ML). THE PATIENT WAS SENT TO THE OPERATING ROOM URGENTLY FOR OPEN-HEART EXPLORATION AND HAEMOSTASIS TREATMENT. DURING THE OPERATION, THE PATIENT WAS CAREFULLY OPERATED TO STOP BLEEDING ADEQUATELY. POSTOPERATIVELY, THE PATIENT'S VITAL SIGNS WERE CLOSELY MONITORED, AND THE STABILITY OF THE INTERNAL ENVIRONMENT WAS MAINTAINED TO MINIMIZE THE OCCURRENCE OF ARRHYTHMIA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS IN GOOD HEALTH. IT WAS ALSO INDICATED THAT THE CAUSE OF THE INCIDENT COULD BE RELATED TO : THE PATIENT'S CONDITION IS CRITICAL, THE OPERATION TIME IS LONG, AFTER EXTRACORPOREAL CIRCULATION, THE PATIENT'S COAGULATION FUNCTION IS POO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ventricular Fibrillation

  MAUDE report 18397641 ↗
• InjuryDec 20, 2023Manufacturing, 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

  (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ventricular Fibrillation

  MAUDE report 18362449 ↗
• MalfunctionJun 21, 2023Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170027 ↗
• InjuryMar 28, 2019Material Puncture/Hole; Material Puncture/Hole

  A FEW SMALL HOLES WERE FOUND BETWEEN THE BRANCHES AND THE MAIN BODY OF THE GRAFT. THE GRAFT COULD NOT BE REMOVED BECAUSE IT WAS ALREADY IMPLANTED INSIDE THE PATIENT. NO SUTURING WAS DONE, ONLY PRESSURE AND CLOTTING AGENT WERE APPLIED TO STOP THE BLEEDING. PATIENT WAS NOT INJURED. A VIDEO OF THE EVENT WAS PROVIDED BY THE USER.

  Patient problems: Blood Loss

  MAUDE report 8461341 ↗

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-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-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-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-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-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-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-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-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-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-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-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

…and 5 more.