Hemashield M002020952100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401017622), received between Mar 14, 2022 and Mar 17, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2022Off-Label Use; Off-Label Use

  SEE MFG INITIAL REPORT #1640201-2022-00007. COMPLAINT #(B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13792981 ↗
• InjuryMar 14, 2022Off-Label Use; Off-Label Use

  THIS COMPLAINT INFORMATION WAS RECEIVED THROUGH A FDA MEDWATCH REPORT AND WAS FORWARDED TO THE MANUFACTURER ON 21 FEB 2022. ACCORDING TO THE MEDWATCH REPORT, COMPLAINT IS AS FOLLOWS: "DESCRIBE THE EVENT OR PROBLEM: HEMASHIELD GOLD KNITTED MICROVEL STRAIGHT DOUBLE VELOUR VASCULAR GRAFT FAILED WHILE CANNULATING FOR VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO). REPLACED WITH NEW GRAFT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) SUPPORT. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING);" TO BE NOTED, THE USE OF HEMASHIELD GOLD KNITTED GRAFT FOR CANNULATION IN VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) SUPPORT IS NOT AN APPROVED INDICATION. AFTER CONTACTING THE INITIAL REPORTER, WE OBTAINED THE FOLLOWING INFORMATION ABOUT THE EVENT: ACCORDING TO THE MEDICAL RECORD, THE PATIENT EXPERIENCE BLEEDING FROM THE RIGHT AXILLARY ARTERIAL GRAFT SITE. THE MEDICAL RECORD DOES NOT INDICATE THE AMOUNT OF BLOOD LOSS. IT IS UNKNOWN IF THE PROCEDURE WAS SIGNIFICANTLY PROLONGED. ACCORDING TO THE MEDICAL RECORD, THE PATIENT WAS ON BRILINTA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13755715 ↗

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.