Intergard IGW0026-15Recalls & reported problems
Intervascular Sas · Intergard Woven Straight Collagen Coated Vascular Graft · Class 2 · Implant
- 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 00384401000211), received between Jan 3, 2018 and Oct 23, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Product Quality 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem2
- Device Damaged Prior to Use1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blood Loss1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Product Quality Problem; Product Quality Problem
COMPLAINT #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368433 ↗MalfunctionOct 23, 2025Product Quality Problem; Product Quality Problem
COMPLAINT # (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368425 ↗MalfunctionFeb 17, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
THE EXTERNAL PACKAGING OF THE PRODUCT WAS TORN/ DENTED. THE PRODUCT WAS NOT IMPLANTED, THEREFORE NO PATIENT WAS HARMED. COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13547620 ↗InjuryJan 3, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON (B)(6) 2017, A SEVERE BLOODLOSS OCCURED THROUGH THE WALL OF THE PROSTHESIS DURING AN AORTIC ASCENDA WITH HEMIARCH PROCEDURE. THE BLEEDING WAS STOPPED BY APPLYING HEMOSTATIC AGENTS (GELITA X-SORB ) AND ADMINISTRATION OF COAGULATION DRUG (OCTAPLEX - 2 DOSES), THE SURGERY WAS SIGNIFICANTLY PROLONGED AND BLOOD TRANSFUSION WAS REQUIRED. THE GRAFT REMAINED IMPLANTED, THE PATIENT STAYED 4 DAYS AT ICU. NO CONSEQUENCE FOR PATIENT WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 7160015 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.