Intergard HEWAA3010080810/1Recalls & reported problems
Intervascular Sas · Intergard Woven Aortic Arch Collagen Coated Vascular Graft · Class 2 · Implant
All models of Intergard (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00384401010760), received between Mar 15, 2018 and Aug 7, 2026 — classified as 3 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem8
- Manufacturing, Packaging or Shipping Problem4
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement3
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Product Quality Problem
Complaint #(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173515 ↗MalfunctionAug 7, 2026Product Quality Problem
Complaint #(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173358 ↗InjuryMay 16, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
InjuryMay 13, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED TO INTERVASCULAR THAT DURING AORTIC ARCH SURGERY, EXCESSIVE BLOOD LOSS OCCURRED ALONG THE ENTIRE BRANCH CONNECTING TO THE CARDIOPULMONARY BYPASS (CPB). COMPLAINT #(B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22009788 ↗MalfunctionJul 9, 2021Product Quality Problem; Product Quality Problem
SEE INITIAL MFG REPORT # : 1640201-2021-00024. COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12141840 ↗MalfunctionJul 9, 2021Product Quality Problem; Product Quality Problem
SEE INITIAL MFG REPORT #: 1640201-2021-00022. COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12141839 ↗MalfunctionJul 9, 2021Product Quality Problem; Product Quality Problem
SEE INITIAL MFG REPORT # : 1640201-2021-00023. COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12141837 ↗MalfunctionJan 18, 2021Nonstandard Device; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Manufacturing, Packaging or Shipping Problem
SEE INITIAL MFR REPORT 1640201-2021-00002. COMPLAINT # (B)(4).
Patient problems: No Patient Involvement
MAUDE report 11186738 ↗MalfunctionDec 6, 2019Product Quality Problem; Product Quality Problem
SEE INITIAL MFR REPORT #1640201-2019-00091 COMPLAINT #(B)(4).
Patient problems: No Patient Involvement
MAUDE report 9426180 ↗MalfunctionDec 6, 2019Product Quality Problem; Product Quality Problem
SEE INITIAL MFR REPORT 1640201-2019-00090 COMPLAINT # (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9425731 ↗MalfunctionSep 23, 2019Product Quality Problem; Product Quality Problem
COMPLAINT REFERENCE (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9105561 ↗InjuryMar 15, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT, ON (B)(6) 2018, DURING A SURGERY FOR AN ANEURYSMAL DISEASE, A SERIOUS BLEEDING WAS OBSERVED FROM THE GRAFT. THE BLOOD LOSS WAS ABOUT 3.5K CC. HEMOSTATIC AGENT (DICYNONE) AND BLOOD PLASMA WERE USED TO TREAT THE BLEEDING. NO TRANSFUSION WAS REQUIRED DURING THE SURGERY. THE GRAFT REMAINED IMPLANTED. NO CONSEQUENCE FOR THE PATIENT WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 7341073 ↗
Other Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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