Intergard IGW0032-15Recalls & reported problems
Intervascular Sas · Intergard Woven Straight Collagen Coated Vascular Graft · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401000273), received between Jun 13, 2017 and Mar 27, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Product Quality Problem1
Patient problems
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2019Product Quality Problem; Product Quality Problem
ACCORDING TO THE SURGEON, THE SURGERY DID NOT HAPPEN AS USUAL. THE INVOLVED GRAFT WAS NOT FLEXIBLE AND WAS DIFFICULT TO HANDLE INTRAOPERATIVELY. A SMALL SAMPLE OF THE GRAFT WAS RETURNED FOR EXAMINATION. IT IS UNKNOWN IF A PORTION OF THE GRAFT REMAINED IMPLANTED. PATIENT WAS NEITHER INJURED NOR ENDANGERED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8456821 ↗InjuryJun 13, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING A SURGERY PERFORMED ON (B)(6) 2017, A BLOOD LEAKING OCCURRED. IT WAS REPORTED THAT WHEN PUTTING IN PLACE THE GRAFT, THE SURGEON NOTICED THAT THE GRAFT WAS PERMEABLE (UNUSUAL BEHAVIOUR). THE SURGEON HAD TO USE A SUBSTANTIAL AMOUNT OF SURGICEL (HEMOSTATIC AGENT) TO STOP THE BLEEDING. THE HAEMOSTASIS WAS DIFFICULT TO CONTROL. THE PRODUCT REMAINED IMPLANTED. NO CLINICAL CONSEQUENCE FOR THE PATIENT WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 6636906 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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