Intergard IGW0026-30Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401000228), received between May 31, 2017 and Feb 5, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Flaked” (1 report).
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.
Most reported problems
Device problems
- Flaked1
- Manufacturing, Packaging or Shipping Problem1
- Product Quality Problem1
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2021Product Quality Problem; Product Quality Problem
WHEN OPENING THE BOX, THE PHYSICIAN NOTICED THAT THERE WERE STAINS ON THE COVER OF TRAY. THE OUTER BOX WAS CLEAN, SO THE PHYSICIAN DID NOT REALIZE THE CONTAMINATION BEFORE OPENING THE BOX. NORMALLY, THE PHYSICIAN REFUSES TO USE DEVICES WITH THIS KIND OF CONTAMINATION. HOWEVER, IT WAS AN EMERGENT OPERATION IN MIDNIGHT, AND THERE WAS NO SUBSTITUTE GRAFT IN THE HOSPITAL, SO THE PHYSICIAN STILL INSERTED IT IN THE PATIENT. PATIENT STATUS IS STABLE CURRENTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11284814 ↗MalfunctionSep 25, 2020Flaked; Flaked
THE GRAFT WAS MEANT TO BE USED TO OPERATE AN ANEURYSM AND AFTER OPENING THE PRODUCT THERE WAS A PROBLEM OF COLLAGEN PEEL-OFF. THE PRODUCT WAS NOT USED. THE SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10586989 ↗MalfunctionMay 31, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE GRAFT HAS A LENGTH OF ABOUT 10 CM WHEREAS THE LABEL INDICATES A 30 CM LENGTH. THE PRODUCT WAS IN THE DISTRIBUTOR WAREHOUSE AND WAS NOT SOLD TO ANY HOSPITAL. PLEASE NOTE THAT THE EVENT WAS REPORTED TO THE DESIGNATED COMPLAINT UNIT ON APRIL 27, 2017. THE INVOLVED PRODUCT WAS RECEIVED FOR EVALUATION ON MAY 30, 2017.
Patient problems: No Patient Involvement
MAUDE report 6601169 ↗
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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