Hemashield M002020852010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401017776), received between Apr 12, 2019 and Sep 28, 2026 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionSep 28, 2026Stretched

  It was reported to Intervascular that on (b)(6) 2021, an abdominal aortic graft replacement surgery was performed using Hemashield.A 20mm portion of the 20mm x 10mm graft was used to perform an I-shaped replacement in the area from the infrarenal artery to the terminal aorta. The distal end of the I-shaped graft was anastomosed to the left common iliac artery, and a Propaten 8mm ring, end-to-end anastomosed to the I-shaped portion, was anastomosed to the right external iliac artery. One week after the replacement surgery, on (b)(6) 2021, the graft had expanded to 28mm (the entire 20mm graft was expanded), and a large amount of mural thrombus was observed. Further expansion continued thereafter, reaching 32.4mm at 5 years post-surgery. Thrombus was prominently observed distal to the Propaten bifurcation.Complaint # (b)(4).

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 50911465 ↗
• InjuryJan 4, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED : "PROBLEM: BLOOD LEAKS FROM THE CROTCH OF THE Y TUBE. I WAS CLAMPING BECAUSE I WAS ANASTOMOSING THE CENTRAL SIDE, BUT BLOOD WAS FLOWING FROM THE CROTCH PART OF THE LEG. AN ADDITIONAL ANASTOMOSIS IS PERFORMED ON THE ARTIFICIAL BLOOD VESSEL, LEADING TO HEMOSTASIS. IN ANOTHER CASE, THE SAME THING HAPPENED AROUND (B)(6) 2021 ((B)(6), SO THIS TIME, WE WILL CONTACT YOU ABOUT THE PROBLEM. REQUEST FOR FUTURE RESPONSE: THE ACTUAL PRODUCT IS USED AND IS IN THE PATIENT'S BODY. WE CANNOT ANALYZE THE PRODUCT, BUT WE REQUEST A LETTER TO THE CUSTOMER AFTER CONFIRMING WHETHER A SIMILAR EVENT HAS OCCURRED OR NOT AT THE SAME LOT."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13152177 ↗
• InjuryDec 23, 2021Nonstandard Device; Nonstandard Device

  COMPLAINT#: (B)(4). SEE MFG REPORT(S) 1640201-2021-00041.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13076690 ↗
• MalfunctionApr 12, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A PROCEDURE, UPON OPENING THE GRAFT, IT APPEARED TO BE A BROWN SPOT ON THE GRAFT. THE GRAFT WAS NEVER IMPLANTED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PHYSICIAN ASSOCIATED. NO PATIENT INVOLVEMENT. THE DATE OF THE EVENT IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8510183 ↗

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-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-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.