Intergard IGK0020-40Recalls & reported problems
Intervascular Sas · Intergard Knitted Straight Collagen Coated Vascular Graft · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401001409), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Moisture or Humidity 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.
Reports received per month
Most reported problems
Device problems
- Moisture or Humidity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Moisture or Humidity Problem
IT WAS REPORTED TO INTERVASCULAR THAT THE CUSTOMER ALLEGED THAT HUMIDITY LEVELS WERE OVER 80% FOR MORE THAN 24 HOURS AND DID REACH 100%. THE DISTRIBUTOR, INTERMED HAD ONE OF REPS VISIT THE CUSTOMER SITE FOR AN ON-SITE INSPECTION OF THE PRODUCTS. SOME PRODUCTS HAD BUBBLING ON THE LABELLING. IT WAS DESCRIBED THAT ALL PRODUCTS FELT COLD AS IF LIKE THEY WERE DEFROSTED. IT WAS SUSPECTED THAT THE PRODUCTS WERE EXPOSED TO EXTREMELY HIGH LEVELS OF MOISTURE. THE IMPACTED PRODUCTS INCLUDE 12 INTERVASCULAR HEMAGARD AND INTERGARD GRAFTS. TWELVE SEPARATE COMPLAINTS WERE CREATED FOR EACH AFFECTED PRODUCTS. ACCORDINGLY, TWELVE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED. THIS EMDR IS PART OF A SERIES OF TWELVE EMDRS SUBMITTED FOR THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714685 ↗
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.