Intergard HEWAA2810080810/1Recalls & 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
- 12
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00384401010753), received between Mar 15, 2018 and Feb 2, 2026 — classified as 6 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (7 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
- Product Quality Problem7
- Manufacturing, Packaging or Shipping Problem3
- Insufficient Device Problem Information2
- Material Puncture/Hole2
Patient problems
- Hemorrhage/Blood Loss/Bleeding4
- No Patient Involvement4
- Blood Loss2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2026Material Puncture/Hole
IT WAS REPORTED TO INTERVASCULAR THAT ON (B)(6) 2025, DURING A TRIAL RUN BEFORE USING THE ARTIFICIAL BLOOD VESSEL, A HOLE WAS DISCOVERED, CAUSING BLEEDING. THE LEAKING PORTION WAS SUBSEQUENTLY REMOVED. PATIENT INFORMATION COULD NOT BE TRACED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24232670 ↗InjuryJan 16, 2026Material Puncture/Hole
InjuryOct 27, 2025Product Quality Problem; Insufficient Device Problem Information; Product Quality Problem; Insufficient Device Problem Information
InjuryOct 20, 2025Product Quality Problem; Insufficient Device Problem Information; Product Quality Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR FROM THE HEALTH FACILITY THAT DURING A GRAFT REPLACEMENT SURGERY FOR AORTIC ANEURYSM, BLEEDING OCCURRED ON THE BRANCH OF THE GRAFT. THE BLEEDING WAS DESCRIBED AS LOCAL AND ALONG A SUTURE LINE / ANASTOMOSIS. ADDITIONAL SUTURES WERE DONE TO STOP THE BLEEDING. IT WAS REPORTED THAT THERE WERE NO IMPACT ON THE PROCEDURAL OUTCOME AND NO CONSEQUENCE FOR THE PATIENT. COMPLAINT # (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23336221 ↗MalfunctionDec 6, 2019Product Quality Problem; Product Quality Problem
MFR REPORT 1640201-2019-00089. COMPLAINT #: (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9424706 ↗MalfunctionNov 18, 2019Product Quality Problem; Product Quality Problem
WHEN THE CUSTOMER OPEN THE PACKAGE ,THEY FOUND THERE WAS YELLOW BLOT ON THE INNER PACKING.
Patient problems: No Patient Involvement
MAUDE report 9336895 ↗MalfunctionNov 18, 2019Product Quality Problem; Product Quality Problem
MFR REPORT 1640201-2019-00085 COMPLAINT # (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9336892 ↗MalfunctionNov 18, 2019Product Quality Problem; Product Quality Problem
WHEN THE DOCTOR OPEN THE PACKAGE OF THIS GRAFT, THERE WERE SEVERAL UNKNOWN YELLOW BOLTS ON THE SURFACE. (PICTURE PROVIDED SHOWS STAIN ON THE PRODUCT SURFACE).
Patient problems: No Patient Involvement
MAUDE report 9336816 ↗MalfunctionSep 23, 2019Product Quality Problem; Product Quality Problem
SEE MFR INITIAL REPORT FOR COMPLAINT REFERENCE (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9107001 ↗MalfunctionSep 20, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
WHEN THE DOCTOR OPEN THE PACKAGE OF THIS GRAFT, THEY FOUND THE GRAFT IS MUCH SHORTER THAN USUAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9099015 ↗InjuryMar 1, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
A BLOOD LEAKAGE DURING A GRAFT IMPLANTATION PROCEDURE WAS REPORTED. THE GRAFT WAS REMOVED AFTER MULTIPLE LEAKAGES WERE FOUND AND IT WAS REPLACED BY A NEW GRAFT.
Patient problems: Blood Loss
MAUDE report 8383241 ↗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 5.5K CC AND A TRANSFUSION WAS REQUIRED DURING THE SURGERY. HEMOSTATIC AGENT (NOVOSEVEN[SUP]) AND BLOOD PLASMA CRYOPRECIPITATE WERE USED TO STOP THE BLEEDING. THE GRAFT REMAINED IMPLANTED. NO CONSEQUENCE FOR THE PATIENT WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 7341086 ↗
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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