Intergard HEWAA2410080810/1Recalls & reported problems
Intervascular Sas · Intergard Woven Aortic Arch Collagen Coated Vascular Graft · Class 2 · Implant
All models of Intergard (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00384401010739), received between Dec 14, 2015 and Aug 14, 2024 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Use2
- Insufficient Device Problem Information2
- Off-Label Use2
- Flaked1
- Manufacturing, Packaging or Shipping Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Flaked; Flaked
FOLLOW UP 1: COMPLAINT#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19979706 ↗InjuryMar 30, 2022Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information
DURING THE SURGERY, THE SURGEON NOTICED A BLEEDING AROUND THE GRAFT. THE GRAFT WAS THEN REPLACED BY ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13950196 ↗InjuryMar 25, 2022Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information
DURING THE SURGERY, THE SURGEON NOTICED A BLEEDING AROUND THE GRAFT. THE GRAFT WAS THEN REPLACED BY ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13904600 ↗MalfunctionNov 29, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
ARTICLE HEWAA2410080810 / 1 (B)(4). PACKAGING ARRIVED DAMAGED, CUSTOMER WANTS TO RETURN GOODS. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12880458 ↗MalfunctionApr 23, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
WHEN THE CUSTOMER (DISTRIBUTOR) CHECKED THE RECEIVED GOODS, HE FOUND A PRODUCT BOX DAMAGED. ACCORDING TO THE CUSTOMER, THE SHIPPING BOX OUTSIDE WAS INTACT. COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11715363 ↗MalfunctionDec 10, 2020Product Quality Problem; Product Quality Problem
SEE INITIAL MFR REPORT #1640201-2020-00023 (COMPLAINT #(B)(4)).
Patient problems: No Patient Involvement
MAUDE report 10984179 ↗InjuryDec 14, 2015Manufacturing, Packaging or Shipping Problem
DURING AN ARCH REPLACEMENT PERFORMED ON (B)(6) 2015 TO REPAIR AN AORTIC DISSECTION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING ESPECIALLY THROUGH THE NEEDLE HOLES (500-600 ML/H). PLATELET AND COAGULATION FACTOR WERE USED TO STOP THE BLEEDING. THE DURATION OF THE OPERATION WAS ABOUT 3 HOURS WITH NOTHING ABNORMAL. UNFORTUNATELY, THE HEMOSTATIC EFFECT WAS NOT GOOD, THE PATIENT EVENTUALLY DIED OF HEMORRHAGIC SHOCK. ADDITIONAL CLINICAL INFORMATION INDICATED THAT ANTICOAGULANT MEDICATION WAS USED BEFORE SURGERY, THE ACT RANGE DURING EXTRACORPOREAL CIRCULATION WAS EXTREMELY HIGH AND THE PLATELET DATA OF THE PATIENT WAS LOW.
Patient problems: Blood Loss
MAUDE report 5293011 ↗
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
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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