Hemagard HGK1608Recalls & reported problems
Intervascular Sas · Hemagard Knitted Bifurcated Collagen Coated Vascular Graft · Class 2 · Implant
All models of Hemagard (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00384401014027), received between Dec 26, 2016 and Jul 24, 2023 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Product Quality Problem2
- Manufacturing, Packaging or Shipping Problem1
- Material Frayed1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- Stenosis2
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2023Product Quality Problem; Product Quality Problem
InjuryJul 18, 2023Product Quality Problem; Product Quality Problem
COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED BY THE SURGEON INDICATES THAT THE SURGICAL PROCEDURE WAS PROLONGED BY 30 MIN AND THE PATIENT LOST 300 CC OF BLOOD. THE BLEEDING WAS NOTICED AFTER THE AORTIC ANASTOMOSIS AND THROUGHOUT THE GRAFT (BLUSHING). THE SURGEON RE-CLAMPED THE GRAFT IN ORDER TO STOP THE BLEEDING. NO CONSEQUENCE ON THE PATIENT WAS REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17342842 ↗MalfunctionMar 21, 2023Material Frayed; Material Frayed
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00043 COMPLAINT: #(B)(4). THE REMAINING 6 OTHER CASES ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: 1640201-2019-00039, 1640201-2019-00040, 1640201-2019-00041, 1640201-2019-00042 , 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8952570 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00043. COMPLAINT: # (B)(4). THE REMAINING 6 OTHER CASES ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: 1640201-2019-00039, 1640201-2019-00040, 1640201-2019-00041, 1640201-2019-00042 , 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8950399 ↗InjuryDec 26, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING AN AORTO BI-FEMORAL INTERVENTION PERFORMED ON (B)(6) 2016 IT WAS REPORTED THAT A BLOOD LEAKING OCCURRED THROUGH THE GRAFT. HEMOSTATIC AGENT WAS USED AND PROTAMINE WAS ADMINISTRATED AS ANTIDOTUM ON HEPARINISATION OF THE PATIENT IN ORDER TO STOP THE BLEEDING. THE INVOLVED GRAFT REMAINED IMPLANTED. NO ADVERSE CONSEQUENCE FOR THE PATIENT WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 6203821 ↗
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-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
- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page