Intergard IGK0006-70Recalls & reported problems
Intervascular Sas · Intergard Knitted Straight Collagen Coated Vascular Graft · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401000365), received between Dec 7, 2015 and Dec 7, 2015 — classified as 1 injury.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K964625); 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
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2015Manufacturing, Packaging or Shipping Problem
DURING A REVASCULARIZATION SURGERY PERFORMED ON (B)(6) 2015, THE GRAFT WAS REPORTED TO BLEED. THE GRAFT WAS REMOVED IMMEDIATELY AND ANOTHER DEVICE WAS USED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 5269980 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K964625. One submission often covers many models, so check the product and lot details in each record.
- Z-1427-2010 · Dec 9, 2009 · TerminatedInterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in th
- Z-1439-2010 · Dec 9, 2009 · TerminatedInterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K9842
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.