Hemashield M002020952160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401017516), received between Aug 1, 2025 and Aug 1, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K954848); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO INTERVASCULAR THAT ON (B)(6) 2025 DURING A REPAIR OF RUPTURED MYCOTIC ANEURYSM OF THORACIC AND ABDOMINAL AORTA, USING 16MM RIFAMPIN SOAKED HEMAHSIELD GRAFT, THE CONCERNED GRAFT WAS INCORRECTLY OPENED AND HANDLED ONTO THE STERILE FIELD WITH THE NON-STERILE PACKAGING, DUE TO MISINTERPRETATION OF PACKAGING. THE SEQUENCE OF EVENTS WAS CONFIRMED AS FOLLOWS: "THE CLEAR PLASTIC ANTIMOISTURE POUCH THAT HAS THE YELLOW WARNING LABEL "POUCH IS NOT A STERILE BARRIER" WAS OPENED OUTSIDE THE STERILE FIELD. HOWEVER, THE NON-STERILE OUTER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD. THE STERILE INNER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD AND GRAFT ITSELF WAS STERILE." THIS PATIENT WAS ALREADY UNDER ANTIBIOTICS TREATMENT AND NEEDED TO CONTINUE ANTIBIOTICS DUE TO THE PREOPERATIVE DIAGNOSIS OF MYCOTIC ANEURYSM REGARDLESS OF THE CONTAMINATION ERROR MADE BY THE NURSE. NO PROCEDURAL DELAY WAS REPORTED. THE PATIENT¿S MEDICAL FOLLOW-UP IS PLANNED AT 1, 6 AND 12 MONTHS. AS OF TODAY, NO HARM TO THE PATIENT WAS REPORTED. THE CUSTOMER IS A LONG TIME USER OF INTERVASCULAR PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954848. One submission often covers many models, so check the product and lot details in each record.

• Z-0729-2022 · Jan 14, 2022 · Terminated
  HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive
• Z-0403-2022 · Dec 1, 2021 · Terminated
  Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
• Z-1859-2020 · Apr 7, 2020 · Terminated
  Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affect
• Z-1861-2020 · Apr 7, 2020 · Terminated
  Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affect
• Z-1860-2020 · Apr 7, 2020 · Terminated
  Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affect
• Z-2066-2010 · May 24, 2010 · Terminated
  Hemashield Gold Woven and Knitted Double Vascular Grafts.