Hemashield M002020954080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401017486), received between Jan 12, 2017 and May 14, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE INITIAL MFG REPORT NUMBER : 1640201-2021-00015. COMPLAINT # (B)(4). THIS MDR FOLLOW UP IS PART OF A SERIES OF 2 FOLLOW UP MDRS FOR THE SAME COMPLAINT, ONE REPORT FOR EACH PRODUCT INVOLVED.

  Patient problems: Fungal Infection

  MAUDE report 11828948 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT INFORMATION WAS RECEIVED THROUGH MEDWATCH VOLUNTARY EVENT REPORT (REPORT NUMBER MW5100205) AND FORWARDED TO THE MANUFACTURER. THE DESCRIPTION OF THE EVENT IS AS FOLLOWS: "PATIENT HAD IMPLANTS FOR EMERGENT SURGERY ON (B)(6) 2020, INFORMED BY MEDICAL CENTER ON (B)(6) 2020 THAT THERE WAS A CONCERN REGARDING FUNGAL INFECTION LATER DETERMINED TO BE A POSSIBLE ASPERGILLUS UDAGAWAE SURGICAL SITE INFECTION THAT MAY OR MAY NOT BE ATTRIBUTED TO THE IMPLANTED GRAFT." TWO GRAFTS WERE IMPLANTED IN THE PATIENT ON THE SAME DAY. GRAFTS REFERENCES IMPLANTED ARE M002020954080 (LOT#20E06) AND M00202175424P0 (LOT #19J18). SERIAL NUMBERS ARE UNKNOWN. THIS INFORMATION HAS BEEN RECEIVED BY THE MANUFACTURER ON APRIL, 21 2021; THE COMPLAINT HAS BEEN LOGGED UNDER #(B)(4). THIS MDR IS PART OF A SERIES OF 2 MDRS WITH THE SAME COMPLAINT DESCRIPTION, ONE FOR EACH PRODUCT INVOLVED.

  Patient problems: Fungal Infection

  MAUDE report 11824581 ↗
• MalfunctionMar 1, 2019Flaked; Flaked

  TWO VASCULAR GRAFTS WERE SUTURED TOGETHER AND WERE USED ON THE SAME PATIENT (SEE MANUFACTURER REPORT 1640201-2019-00012 FOR THE OTHER INVOLVED DEVICE). WHEN SUTURING THE GRAFTS TO BE IMPLANTED, IT WAS NOTICED THAT THE COLLAGEN COATING WAS CRUMBLING LIKE BREAD CRUMBS. THE SURGEON WET THE GRAFTS WITH STERILE SALINE AND NO MORE CRUMBLING WAS NOTICED. THE GRAFTS WERE IMPLANTED IN THE ABDOMINAL AREA WITH NO OTHER SIGNS OF ISSUES OR COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8382219 ↗
• MalfunctionJan 12, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE INVOLVED GRAFT WAS USED AS A CONDUIT FOR EXTRACORPOREAL CIRCULATION. THE BLEEDING WAS LOCALIZED AT THE ANASTOMOSIS SITE. IT WAS REPORTED THAT THE SURGEON WAS NOT FAMILIAR WITH THE HEMASHIELD PRODUCTS.

  Patient problems: Blood Loss

  MAUDE report 6245863 ↗

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-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-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-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-2066-2010 · May 24, 2010 · Terminated
  Hemashield Gold Woven and Knitted Double Vascular Grafts.