Hemashield M002020952080Recalls & reported problems
Intervascular Sas · Hemashield Gold Knitted Microvel Straight Double Velour Vascular Graft with Graft Sizer Accessory · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401017615), received between Jul 12, 2024 and Apr 1, 2025 — classified as 1 death, 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use2
- Defective Device1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025Defective Device; Defective Device
IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE STAFF OPENED THE INVOLVED DEVICE, REFERENCE: M002020952080, DIMENSION 8MMX60CM, THEY NOTICED THE GRAFT WAS NOT AS LONG AS IT SHOULD BE. IT IS ABOUT 30CM INSTEAD OF 60CM. THE SEALED POUCH HAS NOT BEEN OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21736765 ↗InjuryJul 15, 2024Off-Label Use; Off-Label Use
IT WAS REPORTED TO INTERVASCULAR THAT WHEN A PATIENT WAS PLACED ON CARDIOPULMONARY SUPPORT WITH AN AXILLARY GRAFT, THE GRAFT WAS LEAKING THROUGHOUT THE WHOLE GRAFT SURFACE AND ALSO AT THE ANASTOMOSIS SITE. IT WAS NECESSARY TO USE 10ML OF FLOSEAL AND ALSO SURGICEL TO HELP WITH THE BLEEDING. THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU); HOWEVER, THE PATIENT HAD TO COME BACK TO THE OPERATING ROOM (OR) FOR BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19745391 ↗DeathJul 12, 2024Off-Label Use; Off-Label Use
IT WAS REPORTED TO INTERVASCULAR THAT WHEN A PATIENT WAS PLACED ON CARDIOPULMONARY SUPPORT WITH AN AXILLARY GRAFT, THE GRAFT WAS LEAKING THROUGHOUT THE WHOLE GRAFT SURFACE AND ALSO AT THE ANASTOMOSIS SITE. IT WAS NECESSARY TO USE 10ML OF FLOSEAL AND ALSO SURGICEL TO HELP WITH THE BLEEDING. THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU); HOWEVER, THE PATIENT HAD TO COME BACK TO THE OPERATING ROOM (OR) FOR BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19728124 ↗
Other Graft, Vascular, Synthetic/Biologic Composite devices
- Hemashield M00202166168P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall3 reports
- Hemashield M002020851890Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall2 reports
- Hemashield M002020952070Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall0 reports
- Hemashield M00202175928P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite10 reports
- Hemashield M00202175208P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- Hemashield M00202175210P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- AlboGraft Polyester Vascular Graft AMC1407Lemaitre Vascular, Inc. · Graft, Vascular, Synthetic/Biologic Composite6 reports
- Hemashield M00202175430P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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