Hemagard HGK1407Recalls & reported problems
Intervascular Sas · Hemagard Knitted Bifurcated Collagen Coated Vascular Graft · Class 2 · Implant
All models of Hemagard (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00384401014386), received between Feb 23, 2016 and Dec 12, 2022 — classified as 14 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Material Too Soft/Flexible2
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Stenosis12
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2022Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED TO INTERVASCULAR THAT THE IMPLANTED GRAFT WAS A SUBSTITUTION FOR "#0020492". THEY USED ONE [GRAFT] ON (B)(6) 2022 AND THE WEEK BEFORE, AND STATED "THE GRAFT WAS VERY SOFT AND FLIMSY AND KEPT KINKING IN THE TUNNEL. LEADING TO 3 REPEATED ATTEMPTS AND CASE BLEEDING. IT IS NOT A SAFE AND ACCEPTABLE ALTERNATIVE". COMPLAINT #(B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15961844 ↗InjuryDec 12, 2022Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED TO INTERVASCULAR THAT THE IMPLANTED GRAFT WAS A SUBSTITUTION FOR "#(B)(4)". THEY USED ONE [GRAFT] ON (B)(6) 2022 AND THE WEEK BEFORE, AND STATED "THE GRAFT WAS VERY SOFT AND FLIMSY AND KEPT KINKING IN THE TUNNEL. LEADING TO 3 REPEATED ATTEMPTS AND CASE BLEEDING. IT IS NOT A SAFE AND ACCEPTABLE ALTERNATIVE". COMPLAINT #(B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15958410 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00044 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, 1640201-2019-00043, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8952657 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00042. 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, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8952656 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00045. 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, 1640201-2019-00043, 1640201-2019-00044.
Patient problems: Stenosis
MAUDE report 8952624 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00041 COMPLAINT: #(B)(4). THE REMAINING (B)(4) OTHER CASES ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: 1640201-2019-00039, 1640201-2019-00040, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8952571 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(4). THE REMAINING 6 OTHER CASES ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: 1640201-2019-00039, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8952569 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00039. COMPLAINT:(B)(4).
Patient problems: Stenosis
MAUDE report 8952456 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00045. 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, 1640201-2019-00043, 1640201-2019-00044.
Patient problems: Stenosis
MAUDE report 8950941 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00044 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, 1640201-2019-00043, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8950530 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00041. COMPLAINT: # (B)(4). THE REMAINING 6 OTHER CASES ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: 1640201-2019-00039, 1640201-2019-00040, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8950261 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00039 COMPLAINT: #(B)(4). THE REMAINING 6 OTHER CASES ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: 1640201-2019-00040, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8950253 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00040. COMPLAINT #(B)(4). THE REMAINING 6 OTHER CASES ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: 1640201-2019-00039, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8950252 ↗InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE MFR REPORT # 1640201-2019-00042. 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, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.
Patient problems: Stenosis
MAUDE report 8950251 ↗MalfunctionFeb 23, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING A VASCULAR SURGERY PERFORMED ON (B)(6) 2016, THE GRAFT WAS WEEPING BLOOD. AFTER THE INITIAL PERIOD OF LEAKAGE, THE GRAFT APPEARED TO FUNCTION NORMALLY. THIS RESULTED IN A GREATER THAN NORMAL BLOOD LOSS. THE OUTCOME WAS REPORTED TO BE FINE, THE GRAFT REMAINED IMPLANTED.
Patient problems: Blood Loss
MAUDE report 5453900 ↗
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
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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