Hemashield M00202175926P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401018643), received between Oct 2, 2018 and Feb 24, 2023 — classified as 3 injuries, 2 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT WHILE PREPARING FOR TOTAL ARCH REPLACEMENT SURGERY, DISCOLORATION WAS FOUND AS THE COLLAGEN MELTED IN THE PRODUCT. THE OPERATION WAS COMPLETED WITH ANOTHER PRODUCT OF THE SAME MODEL STORED AT THE HOSPITAL. THERE WAS NO HARM OR EFFECT ON THE PATIENT. COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434023 ↗
• MalfunctionNov 16, 2020Material Frayed; Device Contaminated During Manufacture or Shipping; Material Frayed; Device Contaminated During Manufacture or Shipping

  SEE INITIAL MFR REPORT #1640201-2020-00021 (COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED ON DEC 15, 2020 AND DEC 16, 2020 CONCERNING THE EVENT: : "THERE IS ONLY SPECULATION THAT THE FOREIGN OBJECT MAY HAVE BEEN BLOWN AWAY SOMEWHERE BECAUSE IT IS A VERY FINE FOREIGN OBJECT." THE CUSTOMER USED "STRAIGHT SCISSOR". THE GRAFT WAS CUT FOR " IMPLANTATION PURPOSE." A BLUE PEN IS "USED FOR SUCH SURGERY TO MARK THE AREA TO BE CUT IN ADVANCE WITH A SURGICAL PEN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10844494 ↗
• InjuryOct 9, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE DOCTOR DID THE OPERATION ON (B)(6) 2019. DURING THE OPERATION, THEY USED ONE HEMASHIELD 4B GRAFT AND FOUND THE CONNECTION BETWEEN THE GRAFT BODY AND THESE THREE BRANCHES WAS BLEEDING A LOT. AND THEN THEY USED THE AUTOLOGOUS PERICARDIUM TO MEND THE BLEEDING SITE. IT TOOK AROUND 15 HOURS TO DO THIS OPERATION BECAUSE OF THE BLEEDING ISSUE AND THEREFORE THEY DELAYED STERNAL CLOSURE FOR THE EDEMA.

  Patient problems: Blood Loss

  MAUDE report 9173731 ↗
• InjuryOct 4, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  SEE INITIAL MFR REPORT 1640201-2019-00077. COMPLAINT # (B)(4).

  Patient problems: Blood Loss

  MAUDE report 9157413 ↗
• InjuryOct 2, 2018Material Puncture/Hole; Material Puncture/Hole

  DURING SURGERY FOR ANEURYSMAL DISEASE, THE GRAFT HAD A SERIOUS HOLE BLEEDING PROBLEM. THERE WAS NO TRANSFUSION DURING THE SURGERY. SURGEON USED DRUGS AS BIOGLUE TO STOP BLEEDING. THE PATIENT REMAINED IMPLANTED AND STABLE.

  Patient problems: Blood Loss

  MAUDE report 7925828 ↗

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

…and 5 more.