Intergard IGW0030-30Recalls & reported problems
Intervascular Sas · Intergard Woven Straight 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401000266), received between Feb 10, 2016 and Apr 4, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K984294); 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. 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 Problem3
- Flaked2
- Manufacturing, Packaging or Shipping Problem2
- Contamination /Decontamination Problem1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2025Material Frayed; Product Quality Problem; Material Frayed; Product Quality Problem
IT WAS REPORTED TO INTERVASCULAR THAT AS SOON AS THE SURGICAL TEAM OPENED THE INVOLVED GRAFT, THEY NOTICED IT WAS SHORTER IN LENGTH AND HAD A THINNER WALL THICKNESS. WHEN THEY OBSERVED THAT SHEDDING OCCURRED WHILE CUTTING THE GRAFT FOR USE, THEY GAVE UP USING THE PRODUCT AND OPENED ANOTHER 30MM GRAFT. UPON MEASURING BOTH GRAFTS, THEY FOUND THAT THE INVOLVED GRAFT WAS 6¿7 CM SHORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774492 ↗MalfunctionMay 22, 2023Flaked; Product Quality Problem; Flaked; Product Quality Problem
MalfunctionMay 22, 2023Flaked; Product Quality Problem; Contamination /Decontamination Problem; Flaked; Product Quality Problem; Contamination /Decontamination Problem
COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16975686 ↗MalfunctionMay 4, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT HAS BEEN STATED BY THE HOSPITAL THAT THERE WAS A DIFFERENT PRODUCT IN THE PACKAGE THAN THE 30 MM GRAFT MENTIONED ON THE PRODUCT LABELING. THE PRIMARY PACKAGING HAS NOT BEEN OPENED. IT HAS BEEN SUSPECTED TO BE A 10 MM OR 12 MM GRAFT INSIDE THE PACKAGE. IT SHOULD BE NOTED THAT THE COMPLAINT SITUATION WAS RECEIVED BY THE (B)(4) AFFILIATE ON JUNE 2, 2016 BUT HAS NOT BEEN FORWARDED TO THE INTERVASCULAR DESIGNATED COMPLAINT HANDLING UNIT. THIS COMPLAINT SITUATION WAS RECEIVED BY THE INTERVASCULAR DESIGNATED COMPLAINT HANDLING UNIT ON APRIL 25, 2017 UPON INVESTIGATION OF A PREVIOUS PRODUCT MIX-UP COMPLAINT (MANUFACTURER REPORT 1640201-2017-00012).
Patient problems: No Patient Involvement
MAUDE report 6543325 ↗MalfunctionFeb 10, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
WHILE OPENING THE GRAFT BEFORE A SURGERY, A 8 MM DIAMETER GRAFT WAS FOUND IN THE PACKAGE WHEREAS THE PRODUCT IS LABELED AS A 30MM-DIAMETER. THE DEVICE WAS NOT USED AND PLACED BACK IN THE BOX. IT WAS RETURNED FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 5427141 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K984294. One submission often covers many models, so check the product and lot details in each record.
- Z-1282-2022 · Apr 29, 2022 · TerminatedINTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in
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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