Intergard IGW0030-15Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401000259), received between Sep 23, 2016 and Apr 20, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 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
- Manufacturing, Packaging or Shipping Problem2
- Device Damaged Prior to Receipt by User1
- Product Quality Problem1
Patient problems
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Product Quality Problem
IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THERE WAS YELLOW DOT ON THE SURFACE OF THE GRAFT. THEN HE USED ANOTHER NEW ONE TO COMPLETE THE SURGERY. COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24922282 ↗MalfunctionDec 14, 2020Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
COMPLAINT #(B)(4). THE FORWARDER HAD A BAD HANDLE OF THE BOX DURING THE TRANSPORT TO THE DISTRIBUTOR. THE PRODUCT BOX IS DAMAGED BUT THE PRODUCT ITSELF IS OK ACCORDING TO THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 11004274 ↗MalfunctionAug 11, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE HOSPITAL REPORTED THAT BEFORE USING, WHILE OPENING THE PACKAGE, THE GRAFT WAS FOUND DAMAGED AT ONE END. A NEW GRAFT WAS USED FOR THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6787650 ↗InjurySep 23, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING A CARDIAC SURGERY PERFORMED ON (B)(6) 2016, BLOOD LEAKING WAS NOTICED FROM THE GRAFT AFTER ANASTOMOSE, WHICH REQUIRED THE ADMINISTRATION OF 2 BAGS OF THROMBOCYTES. THE HEMOSTASIS WAS PERFORMED AND THE GRAFT REMAINED IMPLANTED. THE SURGERY WAS PROLONGED BY ABOUT 1 HOUR. THE PATIENT WAS REPORTED AS DOING WELL.
Patient problems: Blood Loss
MAUDE report 5972615 ↗
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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