Hemashield M002020851680Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401017721), received between Mar 10, 2017 and May 25, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 25, 2026Insufficient Device Problem Information

  THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A LESION IN THE EXTERNAL AND COMMON ILIAC ARTERIES OF THE BILATERAL LOWER EXTREMITIES. A HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT WAS SOAKED IN HEPARIN BEFORE THE PROCEDURE, AND THE GRAFT WAS IMPLANTED VIA AORTOBIILIAC BYPASS WITHOUT ANY ISSUES. TECHNICAL SUCCESS WAS ACHIEVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016, 4 MONTHS AND 11 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A MAJOR ADVERSE LIMB EVENT (INFECTION). THE SEVERITY WAS NOTED AS SEVERE AND THE INVESTIGATOR NOTED THIS WAS CAUSALLY RELATED TO THE STUDY PROCEDURE AND CAUSALLY RELATED TO THE DEVICE. AN INTERVENTIONAL TREATMENT (SURGICAL PROCEDURE) WAS PERFORMED AND THIS ADVERSE EVENT IS NOTED AS RECOVERED WITH SEQUELAE. A SURGICAL PROCEDURE INCLUDING AXILLO-BIFEMORAL BYPASS, REMOVAL OF AORTIC GRAFT, REDO OF AXILLO-BIFEMORAL BYPASS WAS PERFORMED WITH GRAFT REINTERVENTION BUT NO AMPUTATION. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "ON (B)(6) 2016 SUBJECT PRESENTED WITH FEVER, CHILLS, TACHYCARDIAC AND HYPOTENSIVE, COMPUTED TOMOGRAPHY SCAN REVEALED POSS

  Patient problems: Bacterial Infection

  MAUDE report 25267650 ↗
• InjuryMay 22, 2026Insufficient Device Problem Information

  THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A LESION IN THE EXTERNAL AND COMMON ILIAC ARTERIES OF THE BILATERAL LOWER EXTREMITIES. A HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT WAS SOAKED IN HEPARIN BEFORE THE PROCEDURE, AND THE GRAFT WAS IMPLANTED VIA AORTOBIILIAC BYPASS WITHOUT ANY ISSUES. TECHNICAL SUCCESS WAS ACHIEVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016, 4 MONTHS AND 11 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A MAJOR ADVERSE LIMB EVENT (INFECTION). THE SEVERITY WAS NOTED AS SEVERE AND THE INVESTIGATOR NOTED THIS WAS CAUSALLY RELATED TO THE STUDY PROCEDURE AND CAUSALLY RELATED TO THE DEVICE. AN INTERVENTIONAL TREATMENT (SURGICAL PROCEDURE) WAS PERFORMED AND THIS ADVERSE EVENT IS NOTED AS RECOVERED WITH SEQUELAE. A SURGICAL PROCEDURE INCLUDING AXILLO-BIFEMORAL BYPASS, REMOVAL OF AORTIC GRAFT, REDO OF AXILLO-BIFEMORAL BYPASS WAS PERFORMED WITH GRAFT REINTERVENTION BUT NO AMPUTATION. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "ON (B)(6) 2016 SUBJECT PRESENTED WITH FEVER, CHILLS, TACHYCARDIAC AND HYPOTENSIVE, COMPUTED TOMOGRAPHY SCAN REVEALED POSS

  Patient problems: Bacterial Infection

  MAUDE report 25256086 ↗
• MalfunctionOct 15, 2021Inaccurate Information; Inaccurate Information

  COMPLAINT # (B)(4). SEE MFG REPORT NUMBER 1640201-2021-00034.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638005 ↗
• InjuryMar 10, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT ON (B)(6) 2017, DURING A VASCULAR SURGERY, AFTER SUTURING THE PROXIMAL PORTION AND DECLAMPING THE GRAFT, A SMALL PIN HOLE AT THE BIFURCATION OF THE GRAFT WAS NOTICED, CAUSING SOME WEEPING. THE PHYSICIAN TOOK A 5.0 PROLENE SUTURE AND REPAIRED THE HOLE, THE GRAFT REMAINED IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT ANY ADVERSE CONSEQUENCE FOR THE PATIENT.

  Patient problems: Blood Loss

  MAUDE report 6394682 ↗

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